Long-term outcome after routine surgery for pelvic organ prolapse-A national register-based cohort study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is common, and women have an estimated 12-19% lifetime risk for needing POP surgery. Aims were to measure re-operation rates up to 10 years after POP surgery and patient-reported outcomes (PROMs) 5 years after a first-time operation for POP. METHODS: This is a cohort study using the Swedish National Quality Register for Gynaecological Surgery (GynOp). We retrieved information from 32,086 POP-operated women up to 10 years later. After validation, a web-based PROM questionnaire was sent to 4380 women who 5 years previously had standard POP surgery. Main outcome measures were reoperations due to a relapse of prolapse and PROMs 5 years after the primary operation. RESULTS: Among women operated for all types of POP, 11% had re-operations 5 years later and an additional 4% 10 years later, with similar frequencies for various compartments/types of surgery. PROMs yielded a 75% response rate after 5 years. Cure rate was 68% for anterior, 70% for posterior, and 74% for combined anterior-posterior native repairs. Patient satisfaction exceeded 70%, and symptom reduction was still significant after 5 years (p < 0.0001). CONCLUSIONS: Following primary prolapse surgery, re-operation rates are low, even after 10 years. A web-based survey for follow-up of PROMs after POP surgery is feasible and yields a high response rate after 5 years. The subjective cure rate after primary POP operations is high, with reduced symptoms and satisfied patients regardless of compartment. Standard prolapse surgery with native tissue repair produces satisfactory long-term results.

The tension-free vaginal tape operation: Is the inexperienced surgeon a risk factor? Learning curve and Swedish quality reference.

INTRODUCTION: To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees' performance. The aim of this study is to establish a quality reference, to devise comprehensive tension-free vaginal tape (TVT) learning curves and to compare trainees' results to our quality reference. MATERIAL AND METHODS: Using the Swedish National Quality Register for Gynecologic Surgery, we devised TVT learning curves for all Swedish TVT trainees from 2009 to 2017, covering their first 50 operations. These outcomes were compared with the results of Sweden's most experienced TVT surgeons for 14 quality variables. RESULTS: In all, 163 trainees performed 2804 operations and 40 experienced surgeons performed 3482 operations. For our primary outcomes - perioperative bladder perforations and urinary continence after 1 year - as well as re-admission, re-operation and days to all daily living activities, there was no statistically significant difference between trainees and experienced surgeons at any time. For the first 10 trainee operations only, there were small differences in favor of the experienced surgeons: patient-reported minor complications after discharge (14% vs 18.4%, P = .002), 1-year patient-reported improvement (95.9% vs 91.8%, P < .000), and patient satisfaction (90.9% vs 86.2%, P = .002). For both trainee operations 1-10 and 11-50, compared with experienced surgeons, operation time (33.8 vs 22.2 min, P < .000; 28.3 vs 22.2 min, P < .000) and hospital stay time (0.16 vs 0.06 days, P < .001; 0.1 vs 0.06 days, P < .001) were longer, perioperative blood loss was higher (27.7 vs 24.4 mL, P = .001; 26.5 vs 24.4 mL, P = .004), and patient-reported catheterization within 8 weeks was higher (3.9% vs 1.8%, P < .000; 2.5% vs 1.8%, P = .001). One-year voiding difficulties for trainee patients (operations 1-10:14.2%, P = .260; operations 11-50:14.5%, P = .126) were comparable to the experienced surgeons (12.4%). CONCLUSIONS: There is a learning curve for several secondary outcomes but the small effect size makes it improbable that the difference has clinical significance. Our national Swedish results show that it is possible to train new TVT surgeons without exposing patients to noteworthy extra risk and achieve results which are equivalent to the most experienced Swedish surgeons.

Decisions to use surgical mesh in operations for pelvic organ prolapse: a question of geography?

INTRODUCTION AND HYPOTHESIS: Surgical mesh can reinforce damaged biological structures in operations for genital organ prolapse. When a method is new, scientific information is often contradictory. Individual surgeons may accept different observations as useful, resulting in conflicting treatment strategies. Additional scientific information should lead to increasing convergence. METHODS: Based on data from the Swedish National Quality Register of Gynecological Surgery, all patients who underwent their first recurrent anterior compartment prolapse operation between 2006 and 2017 were included (2758 patients). Surgical mesh was used in 56.5%. We analyzed inter-county disparities in and patterns of mesh use over 12 years. To minimize confounding, we selected a group of highly comparable patients where similar decision patterns could be expected. RESULTS: The use of mesh differed between counties by a factor of 11 (8.6-95.3%). Counties with low use of mesh continued with low use and counties with high use continued with high use. CONCLUSIONS: Decisions regarding how to interpret existing scientific information about mesh implants in the early years of mesh use have led to "communities of practice" highly influenced by geographical factors. For 12 years, these groups have made disparate decisions and upheld them without measurable change toward consensus. The scientific learning process has stopped-despite the abundance of new publications and the steady supply of new types of mesh. Ongoing disparity in surgeons' choices in comparable patients has an adverse effect on clinical care. For the patient, this represents 12 years of a geographical lottery concerning whether mesh is used or not.

Repair of recurrent rectocele with posterior colporrhaphy or non-absorbable polypropylene mesh-patient-reported outcomes at 1-year follow-up.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of repair of isolated, recurrent, posterior vaginal wall prolapse using standard posterior colporrhaphy versus non-absorbable polypropylene mesh in a routine health care setting. METHODS: This cohort study was based on prospectively collected data from the Swedish National Register for Gynaecological Surgery. All patients operated for recurrent, posterior vaginal wall prolapse in Sweden between 1 January 2006 and 30 October 2016 were included. A total of 433 women underwent posterior colporrhaphy, and 193 were operated using non-absorbable mesh. Data up to 1 year were collected. RESULTS: The 1-year patient-reported cure rate was higher for the mesh group compared with the colporrhaphy group, with an odds ratio (OR) of 2.06 [95% confidence interval (CI) 1.03-4.35], corresponding to a number needed to treat of 9.7. Patient satisfaction (OR = 2.38; CI 1.2-4.97) and improvement (OR = 2.13; CI 1.02-3.82) were higher in the mesh group. However, minor surgeon-reported complications were more frequent with mesh (OR = 2.74; CI 1.51-5.01). Patient-reported complications and re-operations within 12 months were comparable in the two groups. CONCLUSIONS: For patients with isolated rectocele relapse, mesh reinforcement enhances the likelihood of success compared with colporrhaphy at 1-year follow-up. Also, in our study, mesh repair was associated with greater patient satisfaction and improvement of symptoms, but an increase in minor complications. Our study indicates that the benefits of mesh reinforcement may outweigh the risks of this procedure for women with isolated recurrent posterior prolapse.

Correction to: Impact of surgeon experience on routine prolapse operations.

The article "Impact of surgeon experience on routine prolapse operations", written by Emil Nüssler, Jacob Kjær Eskildsen, Emil Karl Nüssler, Marie Bixo, and Mats Löfgren, was originally published without open access.

Impact of surgeon experience on routine prolapse operations.

INTRODUCTION AND HYPOTHESIS: Surgical work encompasses important aspects of personal and manual skills. In major surgery, there is a positive correlation between surgical experience and results. For pelvic organ prolapse (POP), this relationship has to our knowledge never been examined. In any clinical practice, there is always a certain proportion of inexperienced surgeons. In Sweden, most prolapse surgeons have little experience in performing prolapse operations, 74% conducting the procedure once a month or less. Simultaneously, surgery for POP globally has failure rates of 25-30%. In other words, for most surgeons, the operation is a low-frequency procedure, and outcomes are unsatisfactory. The aim of this study was to clarify the acceptability of having a high proportion of low-volume surgeons in the management of POP. METHODS: A group of 14,676 exclusively primary anterior or posterior repair patients was assessed. Data were analyzed by logistic regression and as a group analysis. RESULTS: Experienced surgeons had shorter operation times and hospital stays. Surgical experience did not affect surgical or patient-reported complication rates, organ damage, reoperation, rehospitalization, or patient satisfaction, nor did it improve patient-reported failure rates 1 year after surgery. Assistant experience, similarly, had no effect on the outcome of the operation. CONCLUSIONS: A management model for isolated anterior or posterior POP surgery that includes a high proportion of low-volume surgeons does not have a negative impact on the quality or outcome of anterior or posterior colporrhaphy. Consequently, the high recurrence rate was not due to insufficient experience of the surgeons performing the operation.

Factors influencing the outcome of surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) surgery is a common gynecological procedure. Our aim was to assess the influence of obesity and other risk factors on the outcome of anterior and posterior colporrhaphy with and without mesh. METHODS: Data were retrieved from the Swedish National Register for Gynecological Surgery on 18,554 women undergoing primary and repeat POP surgery without concomitant urinary incontinence (UI) surgery between 2006 and 2015. Multivariate logistic regression analyses were used to identify independent risk factors for a sensation of a vaginal bulge, de novo UI, and residual UI 1 year after surgery. RESULTS: The overall subjective cure rate 1 year after surgery was 80% (with mesh 86.4% vs 77.3% without mesh, p < 0.001). The complication rate was low, but was more frequent in repeat surgery that were mainly mesh related. The use of mesh was also associated with more frequent de novo UI, but patient satisfaction and cure rates were higher compared with surgery without mesh. Preoperative sensation of a vaginal bulge, severe postoperative complications, anterior colporrhaphy, prior hysterectomy, postoperative infections, local anesthesia, and body mass index (BMI) ≥30 were risk factors for sensation of a vaginal bulge 1 year postsurgery. Obesity had no effect on complication rates but was associated increased urinary incontinence (UI) after primary surgery. Obesity had no influence on cure or voiding status in women undergoing repeat surgery. CONCLUSIONS: Obesity had an impact on the sensation of a vaginal bulge and the presence of UI after primary surgery but not on complications.

Patient-reported outcomes after sacrospinous fixation of vault prolapse with a suturing device: a retrospective national cohort study.

INTRODUCTION AND HYPOTHESIS: Innovations in suturing devices have facilitated sacrospinous ligament fixation (SSF) for the correction of vaginal vault prolapse. It is uncertain if outcomes using suturing devices differ from those using a traditional suturing technique. We hypothesize that no difference exists in the efficacy and safety 1 year after SSF for vault prolapse performed with suturing devices or using a traditional technique. The objective was to compare SSF using a suturing device with traditional SSF for the treatment of vault prolapse, regarding symptoms of prolapse recurrence, patient satisfaction, incidence of re-operation, and complications 1 year postoperatively. METHODS: We carried out a retrospective cohort study using register-based national data from 2006 to 2013. The Swedish Quality Register of Gynecological Surgery includes assessments pre-operatively, at hospital admittance, surgery, discharge, and questionnaires at 8 weeks and 1 year after surgery. Demographic variables and surgical methods were included in multivariate logistic regression analyses. RESULTS: In the suturing device group (SDG, n = 353), 71.5% were asymptomatic of recurrence after 1 year compared with 78.7% in the traditional SSF group (TSG, n = 195); risk difference - 7.3% (95%CI -15.2%; 0.7%). Adjusted odds ratio (aOR) for being asymptomatic 1 year postoperatively was 0.56 (95%CI 0.31; 1.02, p = 0.057). Patient satisfaction was similar in SDG and TSG (78.1% vs 78.4%). Reoperation occurred in 7.4% in the SDG compared with 3.6% in the TSG, risk difference 3.8% (95%CI 0.0%; 7.5%), aOR 3.55 (95%CI 1.10; 11.44, p = 0.03). CONCLUSIONS: Patient satisfaction was similar 1 year after SSF, despite symptoms of recurrence being more likely and reoperation more common after using a suturing device compared with a traditional technique. The methods did not differ with regard to surgical complications.

Native-tissue repair of isolated primary rectocele compared with nonabsorbable mesh: patient-reported outcomes.

INTRODUCTION: We evaluated patient-reported outcomes and complications after treatment of isolated primary rectocele in routine health-care settings using native-tissue repair or nonabsorbable mesh. METHODS: We used prospective data from the Swedish National Register for Gynaecological Surgery and included 3988 women with a primary operation for rectocele between 2006 and 2014: 3908 women had native-tissue repair, 80 were operated with nonabsorbable mesh. No concurrent operations were performed. Pre- and perioperative data were collected from doctors and patients. Patient-reported outcomes were evaluated 2 and 12 months after the operation. Only validated questionnaires were used. RESULTS: One year after native-tissue repair, 77.8 % (76.4-79.6) felt they were cured, which was defined as never or hardly ever feeling genital protrusion; 74.0 % (72.2-75.7) were very satisfied or satisfied, and 84 % (82.8-85.9) reported improvement of symptoms. After mesh repair, 89.8 % (77.8-96.6) felt cured, 69.2 % (54.9-81.3) were very satisfied or satisfied, and 86.0 % (72.1-94.7) felt improvement. No significant differences were found between groups. Organ damage was found in 16 (0.4 %) patients in the native-tissue repair group compared with one (1.3 %) patient in the mesh group [odds ratio (OR) 3.08; 95 % confidence interval (CI) 0.07-20.30]. The rate of de novo dyspareunia after native-tissue repair was 33.1 % (30.4-35.8), comparable with that after mesh repair. The reoperation rate was 1.1 % (0.8-1.5) in both groups. CONCLUSION: Most patients were cured and satisfied after native-tissue repair of the posterior vaginal wall, and the patient-reported outcomes were comparable with results after mesh repair. The risk of serious complications and reoperation were comparable between groups.

Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012.

OBJECTIVE: The purpose of this study was to report the rates and types of pelvic organ prolapse (POP) and female continence surgery performed in member countries of the Organization for Economic Co-operation and Development (OECD) in 2012. STUDY DESIGN: The published health outcome data sources of the 34 OECD countries were contacted for data on POP and female continence interventions from 2010-2012. In nonresponding countries, data were sought from national or insurer databases. Extracted data were entered into an age-specific International Classification of Disease, edition 10 (ICD-10)-compliant Excel spreadsheet by 2 authors independently in English-speaking countries and a single author in non-English-speaking countries. Data were collated centrally and discrepancies were resolved by mutual agreement. RESULTS: We report on 684,250 POP and 410,352 continence procedures that were performed in 15 OECD countries in 2012. POP procedures (median rate, 1.38/1000 women; range, 0.51-2.55 prolapse procedures/1000 women) were performed 1.8 times more frequently than continence procedures (median rate, 0.75/1000 women; range, 0.46-1.65 continence procedures/1000 women). Repairs of the anterior vaginal compartment represented 54% of POP procedures; posterior repairs represented 43% of the procedures, and apical compartment repairs represented 20% of POP procedures. Median rate of graft usage was 15.7% of anterior vaginal repairs (range, 3.3-25.6%) and 8.5% (range, 3.2-17%) of posterior vaginal repairs. Apical compartment repairs were repaired vaginally at a median rate of 70% (range, 35-95%). Sacral colpopexy represented a median rate of 17% (range, 5-65%) of apical repairs; 61% of sacral colpopexies were performed minimally invasively. Between 2010 and 2012, there was a 3.7% median reduction in transvaginal grafts, a 4.0% reduction in midurethral slings, and a 25% increase in sacral colpopexies that were performed per 1000 women. Midurethral slings represented 82% of female continence surgeries. CONCLUSION: The 5-fold variation in the rate of prolapse interventions within OECD countries needs further evaluation. The significant heterogeneity (>10 times) in the rates at which individual POP procedures are performed indicates a lack of uniformity in the delivery of care to women with POP and demands the development of uniform guidelines for the surgical management of prolapse. In contrast, the midurethral slings were the standard female continence surgery performed throughout OECD countries in 2012.

Operation for primary cystocele with anterior colporrhaphy or non-absorbable mesh: patient-reported outcomes.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of primary anterior vaginal wall prolapse repair, using standard anterior colporrhaphy or non-absorbable mesh in a routine health care setting. METHODS: The study was based on prospectively collected data from the Swedish National Register for Gynaecological Surgery. All patients were operated on solely for primary, anterior vaginal wall prolapse between January 2006 and October 2013: 6,247 women had an anterior colporrhaphy, and in 356 a non-absorbable mesh was used. Data were collected from doctors and patients up to 1 year after surgery. RESULTS: The 1-year cure rate for the mesh group was superior to that of the colporrhaphy group with an odds ratio (OR) of 1.53 (CI 1.1-2.13), corresponding to a number needed to treat (NNT) of 13.5. Patient satisfaction, OR = 2.45 (CI 1.58-3.80), and patient improvement, OR 2.99 (CI 1.62-5.54), was also higher in the mesh group. However, patient-reported complications, OR = 1.51 (CI 1.15-1.98), and the incidence of persisting pain in the loin, OR = 3.58 (CI 2.32-5.52), were also higher in the mesh group as were surgeon-reported complications, OR = 2.27 (CI 1.77-2.91), bladder injuries, OR = 6.71 (CI 3.14-14.33), and re-operations within 12 months, OR = 6.87 (CI 3.68-12.80). CONCLUSIONS: Mesh reinforcement, in primary anterior vaginal wall prolapse patients, enhanced the likelihood of anatomical success at 1 year after surgery. However, mesh implant was associated with a significantly higher incidence of bladder injury, reoperations, both patient- and surgeon-reported complications, more patient-reported pain and a longer hospital stay.

Operation for recurrent cystocele with anterior colporrhaphy or non-absorbable mesh: patient reported outcomes.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare patient reported outcomes and complications after repair of recurrent anterior vaginal wall prolapse in routine health care settings using standard anterior colporrhaphy or non-absorbable mesh. METHODS: The study is based on prospective data from the Swedish National Register for Gynaecological Surgery. 286 women were operated on for recurrent anterior vaginal wall prolapse in 2008-2010; 157 women had an anterior colporrhaphy and 129 were operated on with a non-absorbable mesh. Pre-, and perioperative data were collected from doctors and patients. Patient reported outcomes were evaluated 2 months and 12 months after the operation. RESULTS: After 12 months, the odds ratio (OR) of patient reported cure was 2.90 (1.34-6.31) after mesh implants compared with anterior colporrhaphy. Both patient- and doctor-reported complications were found more often in the mesh group. However, no differences in serious complications were found. Thus, an organ lesion was found in 2.3% after mesh implant compared with 2.5% after anterior colporrhaphy (p = 0.58). Two patients in the mesh group (1.2%) were re-operated compared with 1 patient (0.6%) in the anterior colporrhaphy group (p = 0.58). The infection rate was higher after mesh (8.5%) than after anterior colporrhaphy (2.5%; OR 3.19 ; 1.07-14.25). CONCLUSION: Implantation of synthetic mesh during operation for recurrent cystocele more than doubled the cure rate, whereas no differences in serious complications were found between the groups. However, mesh increased the risk of infection.

No difference in length of hospital stay between laparoscopic and abdominal supravaginal hysterectomy--a preliminary study.

BACKGROUND: Although a number of well-designed studies have concluded that laparoscopic hysterectomy is associated with less postoperative pain, reduced hospital stay, and shorter periods of sick leave, thus far, studies on the perioperative and postoperative outcomes of laparoscopic supravaginal hysterectomy (LSH) versus abdominal supravaginal hysterectomy (ASH) are lacking. By applying multimodal intervention program for the postoperative care of patients, the primary aim of the current study was to compare length of hospital stay, time to convalescence, and long-term patient satisfaction between LSH and ASH. METHOD: The study was conducted at the departments of Obstetrics and Gynecology, Skellefteå Hospital and Lycksele Hospital. Forty-seven consecutive women scheduled for supravaginal hysterectomy were randomly assigned to LSH or ASH. Perioperative and postoperative parameters were compared between the two groups. RESULTS: The length of the postoperative hospital stay did not differ between patients undergoing LSH and ASH, but the number of disability days was greater in the ASH group. The operating time was significantly longer in the LSH group compared with the ASH group, whereas the estimated perioperative bleeding was greater in the ASH group. At the 6-month follow-up, 87.0% of patients in the ASH group and 91.3% in the LSH group were satisfied or very satisfied with the overall result of the surgical procedure. CONCLUSION: The present study has indicated that by applying a multimodal intervention program for the postoperative care of patients undergoing supravaginal hysterectomy, the surgical procedure per se is of less importance than generally considered for the length of postoperative hospital stay and long-term patient satisfaction.