false
Catalog
AUGS/IUGA Scientific Meeting 2019
Short Oral Session 2 - Surgical POP
Short Oral Session 2 - Surgical POP
Back to course
[Please upgrade your browser to play this video content]
Video Transcription
We have no disclosures to report. Hysterectomy is traditionally considered to be part of pelvic organ prolapse surgery. Concurrent hysterectomy at the time of prolapse repair is associated with a 1 to 3 percent decreased risk of future prolapse surgery based on a large cohort study, but it's also associated with higher risks of complications. When accounting for patient preferences, 60 percent of patients stated that they would prefer a utero-preserving procedure, assuming the outcomes were equal. When a patient is a suitable candidate for either approach, one must weigh the relative risks of prolapse recurrence, future endometrial pathology, costs, and patient preferences. As a result, the objective of our study is to determine whether hysterectomy versus hysterectomy at the time of prolapse repair is cost-effective. We created a decision analysis model using 3H Pro, comparing transvaginal hysterectomy with utero-sacral ligament suspension to transvaginal hysterectomy with sacro-spinous ligament suspension. We reviewed high-quality primary literature, systematic reviews, and meta-analyses. Two co-investigators reviewed the literature to generate the probability of an event occurring. For our model, we assumed that all women were over the ages of 65 years old without any immediate contraindications to uterine preservation. This was defined as no postmenopausal bleeding, no history of abnormal pap tests, and no personal or family history of gynecologic or breast malignancy. We further assumed that prolapse recurrence would be treated with minimally invasive laparoscopic sacral-colcomplexy. For women who had undergone a hysterectomy, we assumed that they will receive a hysterectomy at that time. Lastly, we assumed that any woman with a uterus could develop postmenopausal bleeding. Based on recommendations from ACOG, we evaluated all women with postmenopausal bleeding with an abdominal and pelvic ultrasound. All women with an endometrial stripe of greater than 4 mm underwent an endometrial biopsy, and depending on the results of the endometrial biopsy, they either underwent expectant management, hysteroscopy, or surgical management by a GYN oncologist. Costs were gathered from Medicare reimbursement data in 2019 U.S. dollars to include the costs associated with the index surgery, workup for postmenopausal bleeding, and the costs associated with the management of endometrial cancer. In our model, we measured effectiveness as a willingness to pay in the prevention of cancer deaths. We used the Department of Transportation's value of statistical life, which is estimated to be between 5.8 to 7.4 million dollars. If the cost of an intervention is less than that of the value of statistical life, then that intervention is considered to be cost effective. In this table, we present the cost for each of the surgery, the probability of prolapse recurrence, and development of uterine pathology. The first column is for hysterectomy. The second column is for hysterectomy, and the third column is the difference between the two groups. We found that hysterectomy with utero-sacral ligament suspension cost 587 dollars more than a hysterectomy. In the hysterectomy arm, we found that 1.1 percent of women needed an ultrasound evaluation for the management of postmenopausal bleeding. Of these, 0.7 percent required an endometrial biopsy. 0.2 percent of these women required a hysterectomy by a GYN oncologist for suspected endometrial cancer. Hysterectomy with utero-sacral ligament suspension prevents 0.2 percent of women from having to undergo a hysterectomy by a GYN oncologist, 0.8 percent of the women from having to undergo a second prolapse surgery for prolapse recurrence, and in total, hysterectomy prevents 1 percent of the women from having to undergo a second major surgery for either prolapse or for suspected endometrial cancer. Since the estimated 5-year survival rate for endometrial cancer is 81 percent, our model shows that it costs 2.69 million dollars to prevent one cancer death. Since this is below the value of statistical life, it is cost-effective to perform a hysterectomy at the time of prolapse repair. We performed multiple one-way sensitivity analyses and confirmed that our model was robust. The limitations of our studies is that we assume that all patients have no contraindications to uterine preserving surgery, and we assume that all surgeons in our model are equally capable of providing uterine preservation and hysterectomy at the time of prolapse repair. The strength of our study included the use of multiple one-way sensitivity analyses. We also used high-quality data and up-to-date clinical guidelines to build our model. In conclusion, while hysterectomy with uterine sacral ligament suspension costs 587 dollars over hysterectomy per case of prolapse, it does prevent 1 percent of women from having to undergo a second major surgery for either prolapse or for suspected endometrial cancer. Hysterectomy at the time of prolapse repair is a cost-effective strategy to prevent deaths from endometrial cancer. Cost-effectiveness is one of the determining factors in the decision to proceed with uterine preservation at the time of prolapse repair. Thank you for your attention. I welcome any questions. Today, I'll be presenting our work looking at whether the alteration of the genital hiatus remains an important risk factor for surgical failure when post-surgery repair rate is high. We have no disclosures. There are two studies that provide an important background for our study, and these two studies found that failure to normalize an enlarged genital hiatus with surgery was associated with a higher risk of surgical failure. But these studies had a low rate of post-surgery repair, under 50 percent. The aim of our study was to determine whether normalization of an enlarged genital hiatus affects the failure rate of native tissue repair when post-surgery repair rate is high as it is in our population. This was a retrospective chart review among women who had native tissue reconstructive prolapse surgery, and to be included, they had to have POPQ data, including the GH, at the preoperative visit and at the six-week postoperative visit. We also recorded their most recently documented POPQ, but they did not have to have this to be included in our study. These patients were all split up into three groups based on the genital hiatus from before to after surgery, and we did this in the same way that those two prior studies I mentioned had done the groupings, into the persistently wide, stably normal, and improved genital hiatus groups, using four centimeters as the cutoff for an abnormally enlarged hiatus. We used several definitions of failure in this study, including anatomic failure and retreatment. For anatomic failure, we included the anterior or posterior vaginal walls beyond the hymen, or a C greater than or equal to minus four, or retreatment with surgery or a pessary. We included a total of 470 women in the study, and when we look at those three groupings, 17% of them were in the persistently wide hiatus group, 19% in the stably normal group, and most of them, 64%, in the improved hiatus group. When we look at whether any baseline characteristics were associated with alteration of the GH, we find that BMI, parity, and having prior prolapse surgery are all associated with the way the GH has changed, with the persistently wide group having the largest BMI, highest parity, and highest percentage of prior prolapse surgery. The bottom row shows the follow-up time, which is not significantly different between the three groups, and is in that one to two year range. Then we can look at all of the procedures that were done, and which ones were associated with alteration in the GH. And here we find that both anterior repair and posterior repair were highest in the improved GH group, with a 76% anterior repair rate and an 83% posterior repair rate in that improved group, and no other procedures were associated with the change. Our overall anatomic failure rates at the six-week post-operative visit was 1.5% failure, and then at the most recent visit, POPQ, it was a 14.5% failure rate. When we look at retreatment, there was a 0.6% rate of having repeat surgery, and no one went on to be retreated with a PASRE. Then our primary outcome, what were the failure rates by GH grouping? Here in this graph, on the x-axis, you can see three different ways of defining failure, and on the y-axis, the percent of failure. Then the three different color bars are those three different GH groups. And here we can see that, in fact, we found no difference in the failure rate defined any of those three ways between those different GH groupings. Finally, we did a logistic regression model to find factors associated with composite failure, combining anatomic and retreatment. And here, as expected, we find that a greater maximum preoperative prolapse size is associated with a higher risk of failure, but there's no association in the change in the GH from preoperative to postoperative and the failure risk. In conclusion, in contrast to prior studies, we found that surgical alteration of the genital hiatus is not, in fact, associated with surgical failure, and that there is an improved genital hiatus among women who had the highest rates of anterior and posterior repairs. We then hypothesized, could our overall low failure rate be related to our high posterior repair rate? Thank you. Jen's in the Pelvic Floor Disorders Network, some background about our study. The operations and pelvic muscle training and the management of apical support loss, also known as the optimal trial and extended optimal trials, were a two by two factorial randomized trial of vaginal native tissue apical prolapse repair and midurethral sling for stress or nerve incontinence that were performed concomitantly. Patients were randomized to sacrospinous ligament fixation or uterus sacral ligament suspension and were further randomized to behavioral therapy with pelvic muscle floor training or usual care. Outcomes were measured at two years for the optimal trial and five years for e-optimal. The aims of this study were to describe the recurrence, re-operation, and re-treatment rates of pelvic floor dysfunction and prolapse, and to determine the independent risk factors for surgical failure and new or worsening pelvic floor symptoms. This was a planned secondary analysis of the optimal and e-optimal participants. Surgical failure was defined, as per the original study, as apical descent of greater than one-third of the total vaginal length, anterior or posterior vaginal wall descent past the hymen, subsequent prolapse surgery, or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as the minimally important difference from baseline subscale scores of the pelvic floor distress inventory. This was defined as 11 for the urinary distress inventory and 11 for the colorectal anal distress inventory, and 34.3 for the pelvic organ distress inventory. Outcomes were measured at six months, then one, two, three, four, and five years. Chi-square and T-test results from bivariate models at each time point and clinical relevance were used to select variables for the final models. And these are the results of our adjusted models. Statistically significant baseline risk factors for surgical failure included Hispanic ethnicity with an adjusted odds ratio of 1.92, also increased length of the perineal body at baseline with an adjusted odds ratio of 1.34, and an elevated baseline POPDI score, indicating more bother or more prolapse symptoms. Risk factors associated with worsening of pelvic floor symptoms in the POPDI subscale score included a lower baseline POPDI score with an adjusted odds ratio of .75. Worsening urinary condom symptoms included significant risk factors of increased vaginal deliveries at baseline and a lower baseline UDI score. The adjusted odds ratios were 1.26 and .86, respectively. Worsening symptoms according to the CRADI subscale score included increased age with an adjusted odds ratio of 1.03 and a lower baseline CRADI score of .95. The odds ratios for these continuous variables were based on a one centimeter increase for anatomic measurements such as the perineal body, a one year increase in age, one additional vaginal delivery, and one MID interval for the subscale scores of the PFDI. In conclusion, Hispanic ethnicity, a larger preoperative perineal body length, and a higher baseline POPDI score indicating further or more severe bother were risk factors for surgical failure up to five years after vaginal prolapse repair. Participants with lower baseline PFDI scores or less bother were more likely to worsen. Risk factors for worsening urinary incontinence symptoms and colorectal anal dysfunction scores were also included a greater number of vaginal deliveries and increased age, respectively. Thank you for your time and I look forward to your questions. Thank you. Thanks for the opportunity to present our work. As pelvic reconstructive surgeons, we are commonly asked by patients about what their recovery will be like after surgery. Though recovery means a lot of different things to patients, it conventionally has been defined as an energy requiring process of returning to normality and wholeness as evidenced by a return to preoperative levels of independence or dependence in activities of daily living and psychological well-being. Much of what we know about recovery after reconstructive surgery has been derived from studies measuring recovery using the 13-item post-discharge surgical recovery scale, or PSR. It includes a variety of questions, including topics related to postoperative emotional state, activity, and social behaviors. The PSR is a psychometrically valid tool found to be responsive to change in patients undergoing reconstructive surgery. A PSR score of 80, corresponding to greater than 85 percent recovery, has been established as the cutoff representing significant post-discharge recovery, which is shown to be achieved at six weeks after surgery. Research utilizing the PSR has shown that the strongest indicator of recovery centered around activity levels, including work and exercise, and that patients may perceive their recovery status based on resuming their normal life activities. Therefore, the aim of our study was to assess the relationship between post-discharge recovery and subjective and objective measures of activity. This study was a secondary analysis of a prospective randomized control trial where patients undergoing prolapse repair were randomized to receive either restricted or liberal postoperative activity instructions. Patient activity was measured subjectively using the Validated Activities Assessment Scale, or AAS, and objectively using accelerometer devices at baseline, two, and six weeks after surgery. Accelerometers are being increasingly used and have been validated for measuring physical activity in surgical patients. Patients also completed the post-discharge surgical recovery questionnaire at two and six weeks after surgery. A total of 196 patients were assessed for eligibility, with a total of 146 patients included in our final analysis. In order to explore the relationship between subjective measures of activity and recovery, we first compared PSR scores to Delta AAS scores. The Delta scores were calculated by subtracting baseline scores from two and six week scores, with negative values representing a decrease in activity from baseline. A Pearson's correlation coefficient was computed, which demonstrated a positive correlation between the variables, with an R value of .5 and an R square of .25. This meant that the AAS scale as a measure of activity provides 25% of the explained variance of the PSR scores. This is consistent with the proportion of activity-based questions seen on the actual recovery questionnaire, suggesting that the remaining 75% of the explained variance of recovery scores is found elsewhere, such as in emotional and social aspects. We then placed crosshairs on the scatterplot to explore how activity related to specific recovery scores. At a PSR score of 80, again corresponding to significant post-operative recovery, we found that there appeared to be an equal number of data points above and below the Delta AAS line marked at zero, which corresponds to baseline activity. This means that at the point post-operatively where patients feel completely recovered, one half of patients are still reporting that they are performing less activity than their baseline prior to surgery. We then assessed the relationship between objective measures of physical activity and recovery. A Pearson's correlation was used to measure the strength of the relationship between PSR scores and various accelerometer-quantified measures of physical activity, including Delta total steps, active minutes, and 10-minute intervals of moderate to vigorous physical activity. We found only weakly positive correlations, suggesting that recovery does not seem to be related to what activity patients are actually performing. After surgery, patient activity may not necessarily meet or exceed baseline levels despite reports of significant post-operative recovery. Recovery and objective physical activity may behave as independent constructs, suggesting that physical activity may not play as large of a role in the feeling of being recovered after surgery as had been previously hypothesized. This may help guide our patient counseling regarding recovery expectations after surgery. Thank you. Good afternoon. My name is Agustina Vendramini. I came from Hospital Italiano from Argentina. This is my disclosure. So the objective is to estimate the incidence of mesh extrusion and reoperation for complication after surgery with transvaginal mesh for product repair and to describe mesh extrusion treatment and explore associated risk factors. So this is a retrospective cohort of patients operated with transvaginal mesh from January 2011 to August 2018. From two territorial reference centers, one is high and the other is low, urogynecology and surgery. And at least they have six months of follow-up. So the median follow-up was 21 months. And from 713 patients with eligibility criteria, we have 432. We excluded 244 because they didn't have a six-month follow-up. And then we excluded 37 for not being in a standard surgery. So the results, vaginal mesh extrusion resulting at 10.41% for patients. And the reparation due to vaginal mesh extrusion at 3.93. So this is the treatment that we perform in our hospital. We have three groups. One has a size more than one centimeter and is the 38%. They went to vaginal surgery. The other group has a size less than one centimeter or equal. But they were symptomatic, so we decided to offer mesh trimming. This is 18%. And the 44%, they were a size less than one centimeter, and they were asymptomatic. So just long-term local extrusion therapies. Group one, we decided a surgical partial excision and then a vaginal flap closure, as you can see in the image, with no interoperative complications, with a median surgical time of 60 minutes, with a median hospital stays of six hours, and with a median time two reparations from the first surgery to the second of 17 months. So risk factor for mesh extrusion, we explore several risk factors. And what we find is to be a risk factor in our group of patients, premenopause, smoking, and concomitant hysterectomy. And then we did the same, but for re-operation. And what we found here is, again, smoking and low-volume urogynecology surgical center. So our conclusions is that extrusion rate is 10.41%, but only 3.93% require surgery, and the step weight management that we performed allowed a good resolution, with short surgery time, with low comorbidities, and to a small result to be a risk factor for mesh extrusion and for re-operation, and high-volume urogynecology surgical center reduced the risk for re-operation. So although it's a retrospective design, it's a cohort of more than 400 patients, with a follow-up of two years in two territory university hospital centers that perform the same practice. Good afternoon. My name is Susan Worley. I'm a third-year resident, and I'm here to present our research about the use of the National Surgery Quality Improvement Program, or NSQIP, surgical risk calculator in patients undergoing pelvic organ prolapse repair. I have no disclosures. As we know, pelvic organ prolapse is a prevalent and growing concern. An estimated 13% of women will have surgery for prolapse in their lifetime, with over 300,000 surgeries performed each year in the United States. This is likely to increase with growing awareness and as the baby boomers age. Post-operative complications are relatively common, affecting up to one-third of patients in some studies. The NSQIP risk calculator was developed by the American College of Surgeons to more accurately predict which patients may experience a complication. This is the risk calculator. You can enter any given procedure by CPT code, as well as 19 preoperative patient characteristics, such as ASA class, functional status, and comorbidities like diabetes or hypertension. The calculator then reports a percentage risk of a post-operative complication occurring. This is broken down into risk of any complication, a serious complication, and specific complications, including pneumonia, return to the OR, or death. The objective of our study was to externally validate the ability of the risk calculator to predict post-operative complications in patients undergoing pelvic organ prolapse repair. This was a retrospective review of 354 patients undergoing major prolapse surgery at an academic medical center. Calculated risk scores were compared to observed complications, and the risk calculator's predictive ability was assessed using C-statistics and Breyer scores. The primary outcome measure was the ability of the calculator to predict any complication. As you can see, most of our patients were younger than 75 and overweight or obese. Almost half were ASA class 3 or 4 and had hypertension requiring treatment. Rare comorbidities included smoking, diabetes, and dyspnea, and other comorbidities were rarer still. These are the major qualifying prolapse procedures. The majority of our patients had either a laparoscopic colpopexy or a utero-sacral ligament suspension. Most surgeries included concurrent procedures, such as hysterectomy, AP repair, perineurophy, or sling placement. In many cases, the primary prolapse procedure carried a lower predicted risk than one of the concomitant procedures. We recorded the predicted risk for both the primary prolapse procedure as well as the procedure conferring the highest level of risk if they differed. These are all of the complications included in the risk calculator's predictive modeling, in decreasing order of prevalence in our study. For example, as you can see in the top row, the predicted risk of any complication was 6.2% or 7.7%, depending on the CPT code used, but the actual complication rate was 28.2%. The risk calculator under-predicted complication risk scores by risk in general, as well as the risk of the most common post-operative complications, which were urinary tract infection and superficial surgical site infection. To evaluate the predictive ability of the risk calculator, we calculated C-statistics and Briar scores. The C-statistic, also known as the area under the curve of a receiver operating characteristic curve, determines the predictive strength of a model. A value of 0.5 is no better than chance, while 1.0 is perfect predictive ability. Modeling models are typically considered reasonable when the C-statistic is higher than 0.7. The Briar score is the mean squared difference between the predicted risk and the actual outcome. The lower the value, the better the predictive ability. As you can see in the red box, for our primary outcome of the occurrence of any complication, C-statistics were 0.54 and 0.52 for the primary prolapse procedure and highest risk procedure, respectively. Briar scores were 0.25 and 0.24. Similarly, poor predictive ability was observed for our secondary outcomes, including serious complications, surgical site infections, and UTI. This figure shows the ROC curve for the calculator's ability to predict the occurrence of any complication. As you can see, the curve displays a predictive ability that is not significantly better than chance, with a C-statistic value of 0.529. Therefore, we concluded that the NISQIP surgical risk calculator displayed poor predictive ability in our cohort of patients undergoing prolapse repair. Strengths of this study include the diverse surgical population, both in regard to patient demographics and surgical procedures performed. Weaknesses include the retrospective design, the impact of individual practice patterns on the results, and the fact that our statistical methods have limited utility in evaluating low-frequency outcomes, which include most postoperative complications, with the exception of UTI and surgical site infection. Being able to accurately estimate postoperative risk enhances a physician's ability to obtain informed consent, a critical aspect of preoperative counseling. Given the limited utility of the NISQIP risk calculator in this population, better predictive models are needed for patients undergoing prolapse repair. Thank you, and I welcome your questions. Thank you, Ayuka, for giving me the opportunity to share the results of our study. I have no financial disclosures. Central Sensitivity Syndrome is an umbrella term given to a group of conditions which share common symptoms with no underlying pathology, and pain being the leading feature. Central sensitization, i.e., amplification of neural signaling within the central nervous system that affects pain hypersensitivity, is the proposed common pathophysiology. This includes conditions such as fibromyalgia, and patients were found to have poor outcomes following orthopedic surgery and also higher symptom bother from their prolapse. Our aim was to compare the outcome of pelvic organ prolapse surgery in women with and without evidence of Central Sensitivity Syndrome. This was a prospective study, and central sensitization inventory was used to identify women with Central Sensitivity Syndrome, which is a validated self-reporting screening tool, and a cutoff score of 40 was used. Women having primary pelvic organ prolapse surgery who could comply and give consent were included. Women requiring concomitant urinary or fecal continence surgery having severe vaginal pain or previous prolapse surgery in the same compartment were excluded. The primary outcome was to assess improvement in pelvic organ prolapse symptom score. The secondary outcome was to assess patient global impression of improvement, subjective widespread pain experience using SF McGill's pain questionnaire, satisfaction with this surgery using acronym X, and objective assessment of prolapse, POPQ. Surgeons were blinded to the status of Central Sensitivity Syndrome, and patients were followed at three to six months following surgery. Success was defined if there was minimal improvement of six points in POPQ score. Symptoms were rated as very much better or much better on PGII scale, and patient feels their expectations are met and they are satisfied. There was improvement in short-form McGill's pain questionnaire score, and the objective prolapse was said to be persistent if the leading edge is present up to or beyond hymen. Seventy-eight women recruited, however, 62 women completed the cycle, 23 women with Central Sensitivity Syndrome, and 39 without Central Sensitivity Syndrome. However, post-operative POPQ information was available only in 38 women due to the fact that patient declined vaginal examination or they have telephone follow-up. The demographics were comparable in both the groups. Women with Central Sensitivity Syndrome have higher pre-operative POPSS score compared to their objective pelvic organ prolapse relative to women without Central Sensitivity Syndrome. This is a busy slide. However, this shows there is improvement in pelvic organ prolapse symptom score in both the groups, but their scores were higher in women with Central Sensitivity Syndrome. Similarly, this trend you will see in McGill's pre-op questionnaires as well as post-op results. Although there was improvement, but the score was higher in women with Central Sensitivity Syndrome. It was interesting to note that only 70% of women with Central Sensitivity Syndrome felt they were satisfied with the surgery compared to 95%, and 74% reported their symptoms were much better or very much better compared to 97% of women without Central Sensitivity Syndrome. The strength of this study that this is the first study to assess the outcome of pelvic organ prolapse surgery with women with Central Sensitivity Syndrome. However, there are several limitations. We used a validated questionnaire to identify patients with Central Sensitivity Syndrome, but no objective testing for central sensitization such as QST. There were small numbers with short period of follow-up, and few patients had post-operative POPQ, but in this day and era, it's more trend towards using the subjective outcome which we have used as POPSS. In conclusion, our study demonstrated that women with Central Sensitivity Syndrome have higher pre-operative pelvic organ prolapse symptom score compared to their objective prolapse, and after surgery, they have less successful subjective outcomes in terms of satisfaction, goal achievement, and persistence of pain. The result did not recommend that you should not be operating in this group of women. However, this allows us to counsel women with realistic expectation about the surgery. Future research is indicated in order to evaluate the interaction between Central Sensitivity Syndrome and surgical intervention and the impact on the symptoms of pelvic organ prolapse. Thank you.
Video Summary
The video discusses several studies related to pelvic organ prolapse surgery. The first study examines the cost-effectiveness of hysterectomy versus uterine preservation during prolapse repair. The researchers created a decision analysis model and found that hysterectomy at the time of prolapse repair was cost-effective in preventing deaths from endometrial cancer.<br /><br />The second study explores the relationship between the alteration of the genital hiatus and surgical failure in high-risk post-surgery repair rates. The researchers found no association between the normalization of an enlarged genital hiatus and surgical failure rates.<br /><br />The third study validates the use of the National Surgery Quality Improvement Program (NSQIP) surgical risk calculator in patients undergoing pelvic organ prolapse repair. However, the study found that the risk calculator displayed poor predictive ability in this population.<br /><br />The fourth study investigates the use of the Central Sensitivity Syndrome as a predictor of surgical outcomes in women with pelvic organ prolapse. The study found that women with Central Sensitivity Syndrome had higher symptom scores and less successful outcomes after prolapse surgery.<br /><br />Overall, these studies provide valuable insights into the cost-effectiveness, risk prediction, and surgical outcomes of pelvic organ prolapse surgery.
Asset Caption
Sharon Jakus-Waldman, MD, Monika Vij, MBBS,MRCOG, Caroline Kieserman-Shmokler, MD, Susan D. Wherley, Agustina Vendramini, Jessica Ton, MD, Olivia H. Chang, MD, MPH, Divya Arunachalam, MD, Sarah L. Evans, MD
Keywords
pelvic organ prolapse surgery
hysterectomy
cost-effectiveness
endometrial cancer
genital hiatus
surgical failure
Central Sensitivity Syndrome
×
Please select your language
1
English