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PFD Week 2018
Concurrent Session #8: Laser/Surgery
Concurrent Session #8: Laser/Surgery
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All right. Got you. Good. Good afternoon. I would like to thank my co-authors for their contributions. These are our disclosures. This trial was funded by a grant from the Foundation of Female Health Awareness. The objective of this trial was to compare six months quality of life and safety outcomes of fractionated CO2 vaginal laser therapy to vaginal estrogen for the treatment of genitourinary syndrome of menopause. This was an IRB-approved, multicenter, randomized clinical trial. Inclusion criteria are listed here, mainly the presence of vaginal atrophy symptoms, vaginal dryness of greater than 7 centimeters on a visual analog scale. And no patients could have any prolapse beyond stage 2. These are listed exclusion criteria. These included no prior mesh implantation, vaginal or sacral copopexy. That did not include slings. They had to have a vaginal estrogen washout of one month and no vaginal moisturizers or lubricants for two weeks. The primary outcome of our study was subjective improvement of vaginal dryness using a 10 centimeter visual analog scale. Our secondary outcomes are listed here, and these were evaluations and questionnaires given by blinded nurses. Subjects were block randomized to vaginal estrogen cream or CO2 fractionated vaginal laser. Again, subjects were unblinded, but our research personnel were blinded, and also exams included evaluation of vaginal laxity, elasticity, excuse me. Vaginal laser protocol included three laser applications spaced six weeks apart. Our vaginal estrogen protocol included 0.5 grams of conjugated estrogen cream per vagina daily for two weeks, and then twice weekly for 24 weeks. A priori, we determined that 85 subjects per group required for this non-inferiority trial. This allowed for 90% power, and we allowed for a 15% drop rate, therefore targeting 196 patients in total. Intention to treat analysis was performed with logistic regression adjusting for baseline differences. This is a diagram for our patient allocation. Of note is that 33 received laser therapy and 32 vaginal estrogen, and six-month follow-up included 33 patients in the laser arm and 29 in the estrogen arm. Demographic data were not different between groups, except for the fact that the vaginal laser arm was more paris. Peri-procedural outcomes of laser therapy included, of 33 subjects, 75% of patients stated that they had no or mild discomfort. Approximately 50% of patients had both vaginal and vestibular treatment. This table shows our six-month outcome data. And of note is that for the VMI scores, they remain higher in the vaginal estrogen group, although VMI data were only available for 34 patients, 16 in the laser arm and 18 in the estrogen arm. This table demonstrates our FSFI outcome data. Of note is that the table shows that desire and arousal domains were lower in the laser arm, but were no longer statistically significant after controlling for confounding factors. However, our investigation was under power to draw definitive conclusions. There were 10 adverse events which were temporary, and they were not different between groups. The strength of our study is that it is a single-blinded RCT. We used validated questionnaires, and we had blinded follow-up examinations. It, however, was underpowered due to halting enrollment after 35% were enrolled. In conclusion, at six months, fractional CO2 vaginal laser and vaginal estrogen treatment resulted in similar improvement in GSM symptoms. The satisfaction was similar in the vaginal laser and vaginal estrogen groups, and there were no serious adverse events. This is a list of our references, and I thank you for your attention. Thank you. Thank you very much for allowing us to present our research, which was funded by the Anderley Endowment and the Nobel Centennial Endowment. As you know, robotic surgery is becoming increasingly more common in gynecology, and in prolonged Trendelenburg, which is required of many robotic surgeries, this can cause increased intraocular pressure. We also know that postoperative vision loss, a catastrophic complication of surgery, is thought to be caused by ischemic optic neuropathy, which is thought to be caused by increased intraocular pressure. You may remember from medical school that normal intraocular pressure is between 10 and 21 millimeters of mercury. In previously published studies, all in males, all undergoing prostatectomies, average intraocular pressure increased by 13 to 18 millimeters of mercury, and maximum pressures generated were 24, 36, and 59 in the three previously published studies. Our objective in this study was to look in women at the intraocular pressures that are generated while they're in steep Trendelenburg for robotic surgery. We hypothesized that their intraocular pressure would increase proportionally to the length of the surgery, and that it would also increase proportional to the angle of Trendelenburg of the table. This was a single-site prospective observational trial. We performed a power analysis to see if there would be an intraocular pressure greater than 30, we would only need to enroll 16 subjects, which is thought to be clinically relevant with regards to ocular hypertension and glaucoma, or if we looked at a change in baseline of 33 percent, we would only need to enroll 21 patients. But given that prior studies enrolled 30 and 35 studies looking at intraocular pressure in robotic surgery, we decided that we would enroll 30 subjects as well. We included all women undergoing pelvic surgery that was attempted to be robotic-assisted in our institution. We excluded any women who had existing retinal disease or glaucoma, was unwilling to participate, or could no longer tolerate Trendelenburg. We enrolled 31 women with a mean age of 58 and a mean BMI of 33. The Trendelenburg angle is as you can see there. We enrolled 31 women, and one of them was excluded after induction of anesthesia because she was unable to tolerate Trendelenburg. Intraocular pressures were measured with a tonopen. In our results, you can see here that the left eye and the right eye, marked in different colors, didn't differ throughout the measurement of the intraocular pressure. Here you can also see that pre-table tilt, after initial post-table tilt, after one hour of surgery while they're still in Trendelenburg, and post-operatively, there were significantly different intraocular pressures measured at each time point. Now, as you can imagine, as surgery continues, the quantity of subjects that are exposed to Trendelenburg decreases because the surgery ends. We elected to look at patients who were in the Steve Trendelenburg position for four hours, and they're included in this figure. You can see again that those time points from before table tilt, after table tilt, and post-operative are all significantly different. But, as we had expected that as the duration of surgery went on, that their intraocular pressures would increase, you can see that their time points at one hour, two hours, three hours, and four hours, those intraocular pressures did not differ significantly. Conclusions from this study, we know that Trendelenburg for robotic gynecologic surgery, or TIM-N, increases intraocular pressure. We also know that intraocular pressure decreases after surgery, but at 30 minutes after reversal of anesthesia, it's still above the pre-surgical levels. Additionally, 30 percent of our subjects experienced at least one intraocular pressure that was greater than 30 millimeters of mercury, which is thought to be a clinically relevant cutoff. So looking forward, we want to keep in mind that post-operative vision loss is a catastrophic, devastating, but rare, complication. We know that patients with glaucoma or ocular hypertension may be at increased risk of POVL, and we also know from other studies that topical treatment can help decrease intraocular pressure during surgery, which lays the groundwork for future research. Thank you very much for allowing us to present, and thanks to my attendings who are here who allowed me to enroll their patients as a fellow, and to my mentor, Lennox Hoyt, who gave me the idea for the project. Great. Thank you very much. I want to thank everyone for being here and allowing us to present our research. I'd also like to thank my co-authors for all the hard work put in for this study. Do we have no disclosures? Robotic usage in gynecologic surgery continues to grow, along with reports of musculoskeletal discomfort among robotic surgeons. While there have been many calls for improving ergonomics in robotic surgery, little has been done to improve the working conditions for surgeons. The objectives of this study were to design a robot console configuration methodology to optimize surgeon posture, and to determine the effects of this ergonomic intervention on surgeon posture and musculoskeletal discomfort. This was an IRB-approved prospective cohort study conducted from February to October of 2017. Six fellowship-trained gynecologic surgeons proficient in robot hysterectomy were recruited, three male and three female. Each surgeon performed three robotic hysterectomies using their self-selected robotic console settings. Then, a robotic console ergonomic intervention protocol was developed and implemented by trained ergonomists to improve posture and decrease time in poor ergonomic positions. Each surgeon then performed three additional robotic hysterectomies using the ergonomic intervention settings. All surgeons utilized the da Vinci X-Sci surgical system and were the first case of the day. Here you can see the surgeon with his own console settings on the left side of the screen. Note the flexion of the neck and the trunk. On the right, the same surgeon is now using the ergonomist-derived console settings. The surgeon is now sitting straight up, his neck with minimal flexion, his thigh and leg are at a near 90-degree angle. Surgeons wore inertial measurement unit sensors on their head, chest, and bilateral upper arms during surgery. Take a minute to laugh at Dr. Gephardt. The IMUs are equipped with accelerometers, gyroscopes, and magnetometers to give objective measurements of body posture. IMU data were then analyzed to determine percentage of time spent in ergonomically risky postures is categorized using a modified rapid upper limb assessment. Modified rapid upper limb assessment, or RULA scale, ranges from 1 to 4, with 1 being no risk, 2 mild risk, 3 moderate risk, and 4 high risk. For example, RULA 1 would be no or slight flexion of the neck between 0 and 10 degrees, sitting straight up with 0-degree trunk flexion, and minimal shoulder elevation between 0 and 20 degrees. Conversely, RULA 4, the most risky position, postures include any neck extension, the trunk bent forward or flexed greater than 60 degrees, and shoulders elevated greater than 90 degrees. The percentage of time spent in each of these categories was calculated for each procedure. To assess subjective surgeon-reported pain, validated questionnaires assessing musculoskeletal discomfort were administered prior to and immediately after robotic hysterectomy. These were the Nordic Upper Body Questionnaire and the Surge TLX Questionnaire. Comparisons between the two settings were evaluated using a linear mixed model for the IMU measurements and a logistic regression model for the binary change in pain and discomfort pre- and post-operatively. Following the ergonomic intervention, there was an increase in time spent in low-risk neck position, a decrease in time spent in high-risk neck positions, and a decrease in average neck angle and chest angle when compared to the pre-intervention surgeon-derived console settings. The average percentage of time spent in an awkward position, meaning rule a 2, 3, or 4, was significantly lower for the neck and right upper arm when using the intervention settings. The mean neck and chest angles were also significantly improved following intervention. When using the intervention console settings, there were fewer surgeries with a surgeon-reported increase in neck and right shoulder pain as compared to the surgeon-selected console settings. In conclusion, our ergonomic robotic console intervention settings reduced time spent in high-risk neck positions, or high-risk positions, sorry, reduced surgeon-reported musculoskeletal pain scores, and improved surgeon posture. Thank you. Good afternoon, everyone. My name is Jennifer Angell, and I'm not yet a doctor, Dr. 2B, I'm a fourth-year medical student at the University of Michigan. I'd like to thank AUGS for having me present here today, and I'd like to thank my co-authors and especially my mentor, Dr. Dan Morgan. And today I'll be discussing our analysis of sacrospinous ligament suspension and sacrocopal pexy. We have no disclosures. The aim of our study is to analyze the complication and recurrence rates of sacrocopal pexy and sacrospinous ligament suspension among propensity-matched cohorts of women. We identified cases by CPT code that occurred at our institution between 2007 and 2015. This resulted in approximately 1,000 patients who were eligible for propensity score matching. Propensity matching is matching two cohorts on key variables in order to reduce baseline differences. The variables that we chose to match on are as follows, largely demographics and surgical history. And when propensity matching between the two procedures, we oversample the sacrospinous cohort in order to increase the power of our study, as sacrospinous is the more commonly performed procedure at our institution. This resulted in successfully matching 212 sacrocopal pexy cases to 366 sacrospinous cases. Seventy-two percent of the sacrocopal pexies were performed laparoscopically and robotically. Results. Hospital utilization and complications. For the results section, we'll have sacrocopal pexy on the left and sacrospinous on the right. So sacrocopal pexy had a surgical time more than double that of sacrospinous, had a significantly longer length of stay, but no difference in reoperation within 90 days. Sacrocopal pexy patients experienced more intraoperative complications. Those were predominantly bladder injuries followed by vaginal injuries. Postoperative complications. Voiding dysfunction, defined as being discharged home with a Foley or requiring ISC, was more common in the sacrospinous cohort. There's no difference in urinary tract infections or other postoperative complications. Relapse recurrence. This here is depicting objective prolapse recurrence, defined as prolapse beyond the hymen. And so as you can see, sacrospinous on the right has a larger amount of prolapse in any compartment depicted by the blue bar. And then to the right, anterior is the most common compartment that had prolapse in the sacrospinous group, and that was significantly more than in the sacrocopal pexy group. Subjective recurrence was defined as bothersome bald symptoms. Within the first follow-up period, there was no significant difference between the two groups, but in the second period of 3 to 24 months, the sacrospinous group had significantly more symptoms of subjective recurrence. Despite the sacrospinous groups being more likely to have objective and subjective recurrence, there was no difference across any of the treatments for recurrence in physical therapy, pressure use, or operation for prolapse recurrence. Six of our patients did have complications from mesh that led to surgical intervention. Three of those were for extrusion and two for pain. All six of these patients were sacrocopal pexy patients. Stress urinary incontinence was something else that we looked at. Preoperatively, sacrocopal pexy patients were more likely to have demonstrable stress urinary incontinence, although this difference did not reach statistical significance. Sacrocopal pexy patients were also more likely to have slings placed during their index procedure, but despite sling placement, sacrocopal pexy patients were still more likely to have post-operative stress incontinence, and sacrocopal pexy patients were more likely to utilize an intervention for their stress incontinence. This study is limited by confounding factors that are inherent in retrospective analysis. We did try to limit these by the use of propensity matching, and also selection bias and follow-up attendance, the length of the follow-up period, and the lack of patient-reported outcomes. So in summary, sacrocopal pexy has better anatomic outcomes with less subjective symptoms of recurrence, but more interoperative complications, a higher rate of stress incontinence post-operatively, and a 2.9% rate of re-operation due to much-related pain or extrusion. However, there is no difference in 90-day post-operative complications or a need for retreatment. Thank you. All right, these three presentations are now open for questions from the floor. George Flesch, Boston. The sacro-spinal suspensions, were they unilateral or bilateral, and were they done with sutures or were they done with mesh arms? Thank you. I'll defer this question to my clinical mentor, Dr. Dan Morgan. Thank you. They were unilateral, and they were done with PDFs. So they did not utilize any mesh. So I would just suggest that this result should not be generalized to the way many people today are doing sacro-spinal suspension, which is bilateral and with mesh arms. And I think that the failure rates will turn out to be considerably less than what you have with your techniques. The second comment I would make is that anterior prolapse after sacro-spinal suspension, I think it depends very largely on the technique of the anterior cloporaphy. And again, if certain technical requirements are met, I think that the anterior prolapse rates would be considerably lower. Okay. Thank you. Oh, go ahead. Hi. Liz Evans from UT San Antonio. I just have a question for Dr. Hockenstead. Once you find that ergonomic position, is that something that's easily reproducible or is it something that you have to take a lot of effort to recreate that every time? Yep. So for our study purposes, the ergonomist met with the surgeon. There's a very standardized walk-through protocol. It takes about three minutes. And then those settings were all saved on the robot. So they could easily be pulled up. So every time they sat down, they could hit the button and redo it. And at any time, there are written instructions to be able to reproduce that should the settings get lost along the way or someone comes and plays a prank or something. So I was going to ask you a question about that. So are these instructions from the ergonomist? Yes. Is it something that we need an ergonomist for, or are they basic principles that we can apply without that person? So they started being very complicated, and we had to make them much simpler so that it could be generalizable. And this will be something that we present at another date in terms of it's easier to show with a video how to do it, but written instructions will be in the manuscript when it's published. And it's very, very easy to do. Matt. I have a question about the safety study. Did the improved ergonomics after the intervention, did it alter the surgical time or improve any parameter related to surgical outcomes? Yes. So there was no difference. So we didn't collect surgical outcome, per se, because that would have changed our consent process needed for the study. We were really only studying the surgeons as subjects rather than the patients. But it did not seem to alter time at all, and all the surgeons seemed to be happy with their settings. Brian Stewart. A little more quickly. Has Dr. Gebhardt gone back to his old settings, or is he still using the new settings? Dr. Gebhardt does not use the robot, so. I have a question. I have a question for the other Dr. Gebhardt, because she thought she was going to get off easy. Are you recommending that people who haven't had an eye exam get screened before robotic surgery? That's a really good question, especially given that all of the women who had known ocular pathology were excluded from the surgery, and we know that some of these women were at risk. And we actually found two women who had what would be considered ocular hypertension, so not glaucoma, when we enrolled them in the study. So I'm not to the point that in my practice I'm screening them with intraocular pressures, but it would be a great thing to look at going forward. Okay. Great. Thank you. All right, thank you very much. Thank you for allowing us to present our research. We have no financial disclosures. Erosion of mesh into the bladder or urethra in mesh-based pearly organ pull-out repairs and synthetic maniures and slings is uncommon, but it does occur. Based on numerous case reports and theories, there is little evidence-based data to support appropriate surgical procedures for treatment of mesh erosions of the urinary tract. Yeah, thank you. Therefore, the purpose of this study was to determine the safety and efficacy of different outcomes used in surgical decision of bladder and urethral mesh erosion. A systematic review was compiled after researching electronic databases using keywords of surgical mesh, bladder, urethra, erosion, or degradation. Databases were searched from 1996 through 2016 for articles reporting surgical techniques to remove eroded mesh. We have two independent reviewers, screened 1,034 citations. Titles and abstracts were reviewed against the predefined inclusion and exclusion criteria. We included studies evaluating the management of mesh erosions in female bladder or urethra. We excluded studies with animal studies and those that did not discuss management strategies in human bladder or urethra. Editorial content and review articles were also excluded. So we have a total of 1,356 records identified through a database. Searching 1,034 records were screened and 277 full-text articles assessed, and we have 100 studies included in our qualitative synthesis. And statistical analysis was used. There are three major types of surgical approaches found after review, and they were cystoscopic, transvaginal, and abdominal. There are a total of 178 patients included in this study, 96 patients with bladder erosion and 81 with urethral erosion. Of those who had bladder mesh erosion, 78 of them underwent cystoscopic removal, and 18 of them underwent abdominal. It's either open or laparoscopy. And of the patients with urethral mesh erosion, 41 underwent cystoscopic removal and 40 transvaginally. Time-to-erosion is bearable among all the groups. Majority of the mesh placement indication is for stress-reducing incontinence. The most common presenting symptoms were pain and voiding and irritated voiding symptoms, as shown next to the bottom two arrows. For success rate of removal of the mesh, abdominal approach for bladder mesh removal and transvaginal approach for urethral mesh removal is more successful than cystoscopic removal. Most approaches require additional reoperation to remove the remaining mesh, except for abdominal approach for bladder mesh removal. Time-to-symptom resolution, although length of follow-up is bearable across all groups again, many women had residual symptoms regardless of successful removal of mesh. Bladder mesh erosion group had same complete resolution rate between cystoscopic and abdominal approaches. As for urethral mesh erosion removal, 63% of women reported complete resolution with transvaginal approach while 56% for cystoscopic removal. Of those who had residual symptoms, many reported stress-reducing incontinence. Summary of results. A total of 177 women with mesh erosion underwent cystoscopic, vaginal, or abdominal removal of eroded mesh. 63% of patients with vaginal removal of urethral mesh experienced complete symptom resolution compared to 56% in the cystoscopic group. Cystoscopic approach had a complete symptom resolution rate of 78% in those with bladder erosion and same 78% in abdominal approach. The re-op rates are 22% for cystoscopic urethral mesh removal, 5% for transvaginal urethral mesh removal, 19% for cystoscopic bladder mesh removal, and none for abdominal bladder mesh removal. A major limitation of this study is case theory's nature of the study and specific site of mesh erosion in bladder or urethral symptoms not specified in these case studies. Strength of the study is that we reviewed over 100 patients and might describe a generalizable study of most common mesh erosion cases. In conclusion, vaginal approach for repairing urethral mesh erosion has higher complete symptom resolution rate and less re-operation rate compared to cystoscopic approach. Abdominal and cystoscopic approach for bladder mesh erosion have similar symptom resolution, but abdominal approach requires less re-treatment. Thank you for your attention. Thank you to the Society for allowing us to present today. These are our disclosures. This is a Coloplast-funded study. Restorel SmartMesh is an ultralight macroporous polypropylene mesh graft intended for pelvic floor reconstruction. Two grafts are currently made for sacral-copal suspension, the Restorel Y-Mesh and the Restorel L-Mesh, which is a flat mesh that can be cut and configured into two separate dual arms. Surgeons can make significant contributions to cost containment in the operating room. This includes choosing materials that may make certain procedures faster and more efficient. It is unclear if one version of the Restorel mesh is faster to use than the other and if this savings in time translates to theoretic cost savings in the operating room. Therefore, the primary objective of this study is to compare case and mesh placement time between Restorel Y-Mesh and the L-Mesh. The secondary objective is to compare subjective patient symptoms, prolapse recurrence, and the incidence of mesh erosion between the two types of mesh. This was a randomized single-blind trial of women undergoing laparoscopic or robotic sacral-copalpexy for post-hysterectomy vaginal apex prolapse. All subjects were predetermined by their surgeon to undergo either a laparoscopic or robotic sacral-copalpexy. Once subjects were enrolled, they were randomized to either Y-Mesh or flat mesh. Patients were blinded to their allocation. In the operating room, study personnel opened envelopes containing this mesh allocation. A total of four surgeons participated in the trial and procedures were performed per protocol. Case time was defined as incision time to time of closure. Mesh placement time was defined as time from mesh introduced into the abdomen to placement of the last sacral stitch. Surgical technique, including type of suture and number of sutures placed, was standard among all surgeons. Subjects underwent POP-Q exam and completed the PFDI-20 preoperatively and at 6, 12, and 24 months postoperatively. Subjective recurrence was defined as symptomatic vaginal bulge. Objective recurrence was defined as descent of the apex greater than one-third into the vaginal canal, anterior-posterior vaginal descent beyond the hymen, or retreatment for prolapse. Twenty-five subjects in each arm were needed to detect a difference of 20 and 40 minutes or more in suturing and case time, respectively, with 80 percent power and a significance level of 0.05. We accounted for potential subject dropout and lost a follow-up and planned to recruit 30 subjects to each arm for a total of 60 subjects. Sixty-two subjects were enrolled and 59 were implanted with mesh, with 30 subjects randomized to the Y mesh and 29 subjects randomized to the flat mesh. Here we show patient characteristics by mesh type. There were no differences in baseline characteristics. Here we show patient characteristics by route of surgery. Again, no differences were noted in baseline characteristics. And here we present our intraoperative data. Case time and mesh placement time are no different between the two types of mesh. There were no intraoperative adverse events in either group. Six-month outcomes were available for 55 patients. PFDI scores improved for all subjects with no differences in mean improvement by mesh type. At six months, three subjects reported vaginal bulge symptoms and no subjects were retreated for prolapse or were found to have recurrent prolapse on exam. There were also no mesh erosions. Strengths of the study include our prospective randomized design. In addition, our surgeons performed both the laparoscopic and robotic procedures in a standard fashion to prevent technique biases. We also used strictly defined outcomes that were determined a priori to the study being performed. And subjects were blinded to their mesh type, which was important to reduce the introduction of bias with regard to our subjective secondary outcomes. Our biggest limitation is the generalizability of our findings. All four surgeons performing the procedure were comfortable using both the Y-mesh and flat mesh. In other practices, familiarity may be lacking with regard to one type of mesh, and so efficiency may not be the same between the two mesh types. Lastly, we only report six-month outcomes in this paper, and so both our objective and subjective findings may be an overestimate of our true prolapse recurrence and mesh erosion outcomes. We are funded to report our two-year outcomes once we've collected those. When it comes to RestoreL Y-mesh and L-mesh, surgical case and mesh placement times do not differ in patients undergoing either robotic or laparoscopic sacrocopalpexy. Subjective and objective outcomes at six months seem to be excellent with both types of mesh. Thank you, and I welcome all questions. Thank you. All right. My name is Suzanne Lababidi, and I'm a fourth-year resident at the University of Kentucky. I want to thank the committee, as well as everyone else, for allowing me to speak today, as well as my co-authors. We have no disclosures. The prevalence of symptomatic pelvic organ prolapse in the U.S. is estimated to be approximately 20 to 25 percent. The contribution of smoking to this etiology has been debated, however, is known to be a potential impacting factor. That being said, smoking is well-established as a risk factor for postoperative complications in the general surgery literature. It, however, has been poorly studied in urogynecologic procedures, and has been well-established as a risk factor for mesh erosion, however, the literature appears to stop there. So we decided to examine the association between smoking and postoperative complications in pelvic organ prolapse correcting surgeries. We hypothesized that smoking would increase the incidence of postoperative complications in patients undergoing these procedures. We utilized a retrospective cohort design, using the NISQIP database for the years 2012 to 2016. We included all procedures aimed at resolving pelvic organ prolapse, specifically those utilizing vaginal reconstruction, mesh procedures, as well as transabdominal, laparoscopic, and vaginal approaches. Our own exclusion criteria was incomplete data within the database, and we utilized binary logistic regression models to compare these outcomes. We also used chi-square tests and student t-tests to compare baseline characteristics between the two cohorts. This is a list of the procedures that we included within our analysis. For our outcomes, we examined wound complications, specifically superficial, deep, and organ space surgical site infection, as well as wound dehiscence. We also examined the incidence of embolic phenomenon, pneumonia, renal insufficiency, as well as hospital re-operation and re-admission. This demonstrates our baseline characteristics for our two cohorts. As you can see, there is actually a fairly significant difference between the smoking and non-smoking population. Smokers were on average younger, more likely to be white, non-diabetic, and non-hypertensive. So for all intents and purposes, aside from their smoking status, appeared to be a younger, more healthy cohort. That being said, the incidence of wound complications in the smoking cohort was significantly higher than the non-smoking cohort. The incidence of superficial surgical site infection increased by approximately 60%, and the incidence of deep surgical site infection nearly tripled. Looking at other post-operative complications, there didn't appear to be any significant difference in renal insufficiency, DVT, or pulmonary embolus. The incidence of pneumonia did appear to increase in the smoking population, however, this finding was not found to be significant. And then when examining hospital re-admission and re-operation, we did find a significantly increased risk of re-admission and hospital re-operation in smoking patients when compared to their non-smoking cohort. This study utilized a large patient sample obtained from a national multi-institutional database, which allowed it to be generalizable to the majority of patients treated nationwide. That being said, it is limited by the fact that it is a retrospective study and a database study in which the variables obtained were unable to be interrogated further. Additionally, long-term outcomes are unavailable with this data. This study demonstrates that infection, re-admission, and re-operation rates were significantly higher in patients who smoked within the past year. Given the fact that pelvic organ prolapse correcting procedures are often elective, it is important to recognize that patient selection and surgical timing are crucial in optimizing patient outcomes. In the future, we hope to transition to a prospective cohort study examining the impact of delaying surgery with smoking cessation, as well as implementation of smoking cessation methods among patients. Additionally, we would like to look at prolapse-specific outcome comparison between these two patient cohorts. Thank you. So these posters are now open for questions. Cecile, can I ask you a question? I thought that it was well established at the clinic that robotic surgery was slower than laparoscopic surgery. And I'm just wondering if now, is it that you've worked through the learning curve, that you didn't have to, you know, account for that difference? Or is it that you used, you're statistically controlled for that when you were looking at the comparison of the two methods? Thank you. I like it when people ask the clinic folks about our robotic surgery. So if you look at our data sets, there was no difference in mesh suturing time in terms of when we looked at the different meshes. So case times, there's nothing statistically significant comparing between the meshes. But overall, our robotic times were longer than our laparoscopic times. And we didn't, so if we look at the actual, if you do robot versus laparoscopy, our times were different. But if you look at it when we're looking at actual, the mesh within the actual subgroup, there were no differences in which mesh. So comparing Y mesh to dual mesh, laparoscopic to laparoscopic, robotic to robotic, and the actual suturing time within both modalities. But our robotic cases still do take longer than our conventional laparoscopic cases. Drew? I have a question on the mesh erosion study. There were patients that had mid-urethral mesh erosions from slings. Did you notice a history of prolonged catheterization needed after the mesh was placed? So we reviewed all these cases, they didn't elaborate more on that, but I can definitely look into it. But a lot of these cases don't have all the information that we desire. Go ahead, Agnes. I enjoyed all the presentations, but my question is for Cecile again. Cecile, we've trained, one comment and one question. We've trained our tech to make a Y out of a flat mesh, and we save about $200. My question to you is, did you look at the price difference between your flat mesh or the L mesh versus the Y mesh? Yes, our cost difference is $100. One of them costs $6.75, and the other one is $7.75 in our operating system. So the interest was, you know, you think $100 margin may not be that much, but if you're doing $100 a year, that's $10,000. So the real question is, if you actually are faster with one type of mesh, could you save small incremental costs? And that was our thought process, was to see whether or not it was more efficient. But it's a $100 difference in ROR. My question is also regarding the mesh excision study. In my understanding, right, this is a systematic review. Were there any comparative trials that you included out of those 100, or were they all single-arm studies? So they're all from, like, single institution. They were not comparing. If there were, in those literature searches, some of them included transvaginal, and some got it from the same surgeon, but they're not, no systematic comparative. So we don't have any comparative data in the literature on the topic. Right, so that's the limitation for that. Thank you. A quick question. Using the two different types of mesh, some people who use the L, you know, like to tension it differently. They use the tube straps, so they can tension the anterior more than the posterior, or vice versa, or something. Did you guys, is your tensioning technique any different for the Y versus the L, or is it the same? No, it was at the surgeon's discretion in terms of how to sort of tension it. So, and that's a surgeon by surgeon. All of us sort of think a little bit differently about how to tension. I think we tend to tension the Y in a very standard fashion, whereas the dual, the flat mesh is used to tension maybe the anterior wall a little bit differently than the posterior. But what we did do was standardize the number of sutures placed along all the compartments so that timing wouldn't be affected by the way that we were actually choosing our tensioning. Okay. Thank you very much. Thank you very much. We'll go on to the office or the emergency room at a higher frequency post-operatively. Presented by Dr. Cope. Good afternoon. Can you guys hear me? I know. Hi, I'm Zeb. I'm a fourth year resident from Michigan State University, and I have the good fortune of presenting our study post-operatively. Post-operative length of stay as it relates to post-operative complications. I have no relevant financial relationships to disclose. Our study sought to evaluate whether remaining overnight after a urogyne case compared to being discharged on the same day of surgery had any effect on the frequency and severity of post-operative complications in the immediate six post-operative weeks. Our inspiration came from the evolution of post-operative management with enhanced recovery after surgery protocols, and also just general observation from looking at provider to provider, institution to institution. There's a great variation as to the timing of discharge after a benign gyne case. Our retrospective cohort study spanned from January 1st, 2013 to New Year's Eve, 2016, evaluated over 700 patients that had a surgery by an FPMRS board-certified physician at our institution. Our exclusion criteria included patients that were lost to follow-up, patients that had isolated hysteroscopies or endometrial myomectomies, vaginal mesh revision or excision surgeries, combined surgery with other surgical services, or interstem placements. We collected data on basic demographics, presurgical risk factors, the type of surgery, perioperative data and data on readmission, presentations to the ER in urgent care, post-operative complications at routine post-op visits, and also if a post-op complication required an additional vision. We used a chi-square in Fisher's exact test for categorical data and two sample independent t-tests for numeric data. All significance was assessed at a P of less than 0.05. After applying our exclusion criteria to the 779 patients, we had 608 charts for review. Regarding our two cohorts, we had the same day discharge group, those patients that were discharged on less than 24 hours after their surgery, opposed to the standard care discharge group. The discharge group tended to be a little bit younger, 54 opposed to 58, and a little higher BMI, 29 opposed to 27. There were no differences for smoking, independent living status, or other types of insurance. About 90% of both cohorts were Caucasian. No differences were found for perioperative risk factors of diabetes, preoperative anticoagulation status, nor beta blocker use. For perioperative risk reduction, again, no differences were found for preoperative antibiotics, SEDs, or perioperative heparin. When it came to evaluating the overall complications, we didn't find any significant difference between the two cohorts when it came to ER visits, but we did find that the standard care discharge group, those patients that stayed in-house greater than 24 hours, did have significantly higher rates of post-op complications in the office. So no significant difference as far as readmissions. When we stratified the actual complications in the office, we found that both groups had identical top three complaints. The most common concern was minor infection, as defined by UTI, VEV, or vaginal yeast infection, followed by urinary retention, and then pain. When it came to the ER, we found that the same day discharge group, the most frequent concern was pain. Overall, for our study, it looked like older patients with a lower BMI may require a little bit longer time to recover after reconstructive pelvic surgery. We had no readmissions within the first 48 hours after surgery in either group, nor any major complications from either group. Patients in the same-day discharge group did have a higher rate of pain management concerns when returning to the ER, whereas patients in the standard care group noted more post-operative complications in the clinic. Thank you. Good afternoon. We have no disclosures. However, our study was funded by the Mayer Foundation, the NIH, and the Center for Global Health. Athletic fistulas, as most of you know, are pelvic fistulas that result from prolonged or obstructed labor without timely access to emergency obstetric care. Now, the WHO estimates that there are 2 to 3.5 million women living with this condition, with 50,000 to 100,000 new cases per year. However, these estimates are extrapolated from hospital-based studies. The problem with this is that, in addition to obstructed labor, the pelvic physiology of obstetric fistula involves the lack of ready access to care. So, obviously, if we are extrapolating from hospital-based studies, we may not be capturing all the women with fistulas. In addition, population-based surveys, such as demographic health surveys, have included fistula symptom questions in their surveys. However, the cases have not undergone confirmatory physical examinations. In addition, these surveys have not used validated questionnaire. Currently, there is no widely used, well-validated screening tool for obstetric fistula. The objective of our study was to validate a symptom-based screening questionnaire for obstetric fistula in a higher prevalence setting. Within this questionnaire, we included fistula symptom questions that is used on many demographic health surveys. This screening questionnaire was previously piloted and validated using a case control study design listed within a population-based cross-sectional study in rural Nepal and demonstrated high sensitivities and specificities. However, our confidence intervals were quite wide. And the reason for this is likely that our fistula prevalence in rural Nepal in our study population was quite low. We performed a case control study design. Within our study questionnaire, we included symptoms of lower urinary tract fistula, as well as lower gastrointestinal tract fistula. We also included the fistula screening question that has been included in many demographic health surveys. In addition, we included questions at urinary and fecal incontinence. We performed examinations on all patients, and the examiners were blinded to the questionnaire results. We know from our Nepal study that all the false positives, so all the participants who answered positively to fistula symptoms but actually did not have a fistula on an exam, were urinary incontinence patients. Therefore, we performed a case control study in a 1 to 2 to 2 ratio. So for every case of lower urinary tract fistula, we had two types of controls. We had controls of patients without fistula symptoms and without incontinence, as well as controls of patients with incontinence. A priori, we performed a sample size analysis and determined that we needed 58 cases to validate this questionnaire at a 90% sensitivity and specificity with a 10% margin of error. We recruited 59 patients, and these patients had positive results to our screening questionnaire. We all underwent examinations, and there were three false positive cases. So again, three cases of patients that answered yes to fistula symptoms but were not found to have fistula on examination. We also recruited 240 controls, and these were both women with and without urinary incontinence. And we performed physical examinations on all the women, and importantly, none of the women had fistula, so there were no false negatives. So in terms of our findings, the questions we, well, we tested many questions. The ones that most accurately determined lower urinary tract fistula symptoms were, when you're not urinating, do you routinely or consistently experience continuously dripping urine through the birth canal or vagina that you cannot stop or control? And as you can see here, our sensitivities, specificities, and area under the curves were quite high. In addition, the demographic health survey fistula screening question also performed quite well. Sometimes a woman can have a problem such that she experiences a constant leakage of urine or feces from her birth canal vagina during the day and night. This problem usually occurs after a difficult childbirth, but may also occur after sexual assault or after pelvic surgery. Have you ever experienced, now or in the past, a constant leakage of urine and or stool from your birth canal vagina during the day and night? Interestingly, the questions that performed the best for lower gastrointestinal tract fistulas were a combination of fistula symptom question as well as fecal incontinence question. When you're not having a bowel movement, do you routinely, consistently experience feces passing through the birth canal that you cannot stop or control? Combined with, we would like to ask you about any leakage of feces. Please do not include problems during short-term illness such as a flu or virus diarrhea. Do you have problems with leakage of feces from the anus, accidents, or soiling because of the inability to control the passage of feces until you reach a toilet? Similarly, the demographic health survey fistula question also performed well. So demographic health surveys, for those of you that are not as familiar, are nationally represented healthful surveys, and they provide data on indicators of population health and nutrition and are performed in lower resource settings. They're administered at household levels every five years using sampling techniques so that the results are generalizable countrywide. Therefore, we were able to use our study characteristics as well as DHS data to back calculate the fistula prevalence estimates. And as you can see here, it ranges from 0.12% to 0.73%. And just as a matter of perspective, this is somewhat similar to the WHO estimates as well as somewhat higher in certain countries. The limitations of our study are that our questionnaire was administered by junior-level medical students. And as we're working with the Ministry of Health to administer this questionnaire worldwide, this is something that will be administered eventually by community health workers. And as we know, medical students have a lot more education than community health workers. But it's notable that in Nepal, this questionnaire was administered by female field interviewers with no more than a secondary school education. We may also be subject to spectrum bias. So the women that we recruited as our cases were women that presented for care. Their symptoms may be far more severe than women with fistula symptoms but who do not present for care. However, from a disease burden perspective, it's perhaps arguably less essential to capture those patients. And then lastly, our control patients were patients that came to the provincial hospitals. And so they may not be representative of the entire rural population. But we know from our demographic characteristics such as literacy level and educational level that they're actually quite comparable to population-based reports. So in conclusion, our fistula screening questionnaire demonstrated high sensitivity and specificity. And now this questionnaire has been validated in both a high and a low prevalence setting in sub-Saharan Africa and in South Asia. And as I have mentioned that we can then now use this questionnaire to better estimate the global burden of disease from obstetric fistula. Thank you. Thank you. Good afternoon. Thank you for staying with us to the last presentation. I will be presenting the first steps in our development of a patient-centered pelvic floor complication scale. These are our disclosures, not relevant to this talk. We all know that pelvic floor disorders impact quality of life but are rarely unto themselves morbid. However, there are definitely possibilities and risks involved in pelvic reconstructive surgery that can be quite morbid. And the evaluation of these complications with existing complication scales such as the clavian dindo can be challenging because they are not condition-specific to pelvic reconstructive surgery. They're mostly used for inpatient surgery. They're validated in both men and women. And they really take into account only the perspective of the surgeon. Pelvic floor complication scales that have been published have yet not been simplified, nor do they take into account the perspective of a patient either. So our objective in this talk was to evaluate patient responses on a survey of their knowledge, their perceptions, their concerns, and fears about related complications in pelvic reconstructive surgery, as well as to ultimately create a simplified patient-centered pelvic floor complication scale. This was a prospective, qualitative cohort pilot study of surgically and demographically diverse patients greater than 18 years in age who were planning or had had prior pelvic reconstructive surgery within six months. They were recruited from five fPMRS surgeons, and they took surveys where they responded to free response questions about complications, as well as focus questions where they ranked the severity of specific surgical complications as minor, moderate, or severe. Thirty-three patients were enrolled. Sixteen of them were pre-op. Seventeen of them were post-op. Twenty-six telephone interviews were done in addition to seven focus groups, and there were no differences in the baseline demographics of these patients. Their mean age was 62 years. The majority of them were married, white, non-Hispanic, and had some college or graduate education. As you can see here in this table, we demonstrate the relative severity of several complications as rated by patients, UTI, constipation, and bladder injury. You can see that patients on the whole rated a single UTI after surgery as a minor complication of surgery. However, if they had recurrent UTI after surgery, they were quick to rate that as a moderate or severe complication. Constipation that was new immediately after surgery was in general rated as a minor complication, but persistent constipation after surgery was rated as moderate or severe. Interestingly, bladder injury to a patient who is discharged without a catheter is largely not considered to be a major complication at all. In fact, it is generally rated as minor. But discharge with a catheter was, again, quick to be rated as a moderate or severe complication. We also asked patients about vascular injuries and bleeding, reoperation, and visits after surgery. Patients were really only noted to report a bleeding event as severe if it required a transfusion, and the patient's evaluation of reoperation depended largely on the timing of that reoperation. With regard to visits after surgery, patients were very content with having to go back to the office. They rated repeat office visits or additional office visits as minor complications, but an ER visit with a subsequent admission was rated as severe. One of the more illuminating parts of this study was the analysis of patient's narrative data, where they could answer as a free response, and we used deduce software to quantify themes that emerged from the patient's narrative. You can see on the y-axis the most common themes that emerged from the patient's narrative, and on the x-axis is the number of times it was mentioned. You can see that the most common things patients reported as what they deemed to be complications or concerns were general worry, pain, fear of a catheter, fear of constipation, fear of anesthesia, fear of mesh, and fear of surgical failure. There also emerged some very resounding themes related to patient's trust in their specialists and their concerns about patient transparency during the consent process. To conclude, this study provided significant insight into patient perceptions of pelvic reconstructive surgery complications. It is entirely possible and likely, in fact, that patients and surgeons may perceive complications very differently. This study also highlights some themes that are related to surgical counseling and surgeon transparency that may be important for future studies, but for now, we look forward to using this data to develop in the future a simplified patient-centered pelvic floor complication scale. I'd be happy to answer any questions at this time. This is a word cloud that demonstrates the most significant themes that emerged from the patient's narrative data. Thank you. These papers are now open for questions. Grace, I have a question for you about translations. It seems to me that the semantics of the question in English are very important in trying to distinguish who does and doesn't have a fistula, and I'm just wondering how you control for that in the translation to different languages. How do you really understand if the semantics of the question are indeed translated correctly? Yeah, absolutely. So the questionnaire was translated and then back-translated, and furthermore, we had to culturally adapt it, right, because certain cultures don't say the word vaginas. And in addition, we had to vet it with not only physicians but also community health workers, women with very low levels of education, so the translation, back-translation process was actually pretty onerous, but needed to be that way, I think. Hi, I have a question about patient perceptions of complications. And you were talking about the bladder injury and going home with the catheter was perceived as a severe complication. What about the going home with the catheter just because you had the postoperative urinary retention? Did you look at that one, too? That's a great question, and that was one of the impetuses, I guess, if that's a word, of this study, because patients, you counsel them about it, you warn them that there's a decent chance they'll go home with a catheter from routine surgery, but you'd be amazed that patients go home if they fail their aborting trial and they view that as a complication. They don't necessarily label it as something routine. So were they viewing it as severe? They view it as moderate or severe. They're pretty split between the two, 40 to 50%. How did you guys control, when you were recruiting patients for this, for the patients that we all identify before you do anything to them that they're a difficult patient? And how many difficult patients did you include in this group that you were querying about their concern about complications? That's also a great question, and we definitely thought about that. This was by no means blinded. In general, we relied on the surgeon to identify a patient that would be willing to give an honest interpretation of the surgery they had or were planning. Definitely patients that, you know, using our best judgment would be deemed as maybe not the best patient for this study were not called on the phone. Those are the people that I really want to hear from because I want to have some idea of what their perceptions are of complications. Thank you so much for your attention and for being present. Thank you to our speakers.
Video Summary
The first study presented aimed to evaluate whether remaining overnight after urogynecological surgery impacted the frequency and severity of post-operative complications. The study included 608 patients who underwent pelvic reconstructive surgery and found that patients who remained overnight had a higher rate of post-operative complications during office visits, while the rate of readmissions did not differ significantly between the two groups.<br /><br />The second study focused on the development of a symptom-based screening questionnaire for obstetric fistula. The questionnaire was validated in a high-prevalence setting and found to have high sensitivities and specificities for identifying fistula symptoms. The researchers also used demographic health surveys to estimate the prevalence of obstetric fistula and found it to range from 0.12% to 0.73% in different countries.<br /><br />The third study aimed to develop a patient-centered pelvic floor complication scale. The researchers evaluated patient responses on a survey about their knowledge, perceptions, concerns, and fears related to complications in pelvic reconstructive surgery. The findings from the study will be used to create a simplified patient-centered pelvic floor complication scale in the future.<br /><br />Overall, these studies contribute to the understanding of post-operative complications and patient experiences in urogynecological surgery, and may help guide future research and patient care in this field.
Asset Subtitle
Sarah Huber, MD, Marie Fidela R. Paraiso, MD, Jeffrey S. Schachar, MD, Laura F Gephart, MD MBA, Erik D Hokenstad, MD, Jennifer Angell, BS, Dominique Thomas, BS, Cecile A Ferrando, MD, MPH, Suzanne Lababidi, MD, Zebulun Cope, DO, Chi Chiung Grace Chen, MD, MHS, & Jocelyn J Fitzgerald, MD
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Surgery - Robotic Procedures
Category
Surgery - Fistulas
Category
Education
Keywords
urogynecological surgery
post-operative complications
overnight stay
pelvic reconstructive surgery
office visits
readmissions
symptom-based screening questionnaire
obstetric fistula
prevalence
patient-centered pelvic floor complication scale
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