Colpocleisis: reoperation risk and risk of uterine and vaginal cancer: A nationwide cohort study.

INTRODUCTION AND HYPOTHESIS: We aimed to evaluate the risk of reoperation and uterine (myometrial, endometrial, and cervical) and vaginal cancer after colpocleisis performed during the years 1977-2018. Furthermore, we also aimed to assess the development in colpocleisis procedures performed during the study period. METHODS: Danish nationwide registers covering operations, diagnoses, and life events can be linked on an individual level owing to the unique personal numbers of all Danish residents. We performed a nationwide historical cohort study including women born before year 2000 who underwent colpocleisis between 1977 and 2018 (N = 2,228) using the Danish National Patient Registry (DNPR). We followed the cohort until death/emigration/31 December 2018, whichever came first. Primary outcomes were number of pelvic organ prolapse (POP) operations performed after colpocleisis and uterine and vaginal cancer diagnosed after colpocleisis in a subgroup of women with the uterus in situ. This was assessed with cumulative incidences. RESULTS: During follow-up (median 5.6 years) 6.5% and 8.2% underwent POP surgery within 2 and 10 years after colpocleisis respectively. Within 10 years after colpocleisis 0.5% (N = 8) were diagnosed with uterine or vaginal cancer in the subgroup of women with their uterus (N = 1,970). During the study time 37-80 women underwent colpocleisis yearly and the mean age increased (77.1 to 81.4 years). CONCLUSION: Despite smaller studies showing no recurrence after colpocleisis, we found that 6.5% underwent reoperation within 2 years. Few women were diagnosed with uterine or vaginal cancer after colpocleisis. The increased age at the time of colpocleisis indicates changed attitudes regarding surgical treatment for elderly women with comorbidities.

Increased risk of stress urinary incontinence surgery after hysterectomy for benign indication-a population-based cohort study.

BACKGROUND: Hysterectomy is a common procedure used to treat different gynecologic conditions. The association between hysterectomy for benign indication and stress urinary incontinence has previously been established. Stress urinary incontinence can be treated surgically, and options have improved after introduction of the midurethral sling procedure in 1998. OBJECTIVE: This study aimed to estimate the risk of stress urinary incontinence surgery after hysterectomy for benign indication. STUDY DESIGN: The study was carried out as a matched register-based cohort study including Danish women born from 1947 to 2000. Women who underwent hysterectomy for benign indication were matched to nonhysterectomized women in a 1:5 ratio on the basis of age and calendar year of hysterectomy. The risk of stress urinary incontinence surgery after hysterectomy was estimated. We adjusted for income, educational level, and parity. The risk of stress urinary incontinence surgery was further estimated in a subcohort excluding all vaginal hysterectomies. The joint effect of hysterectomy and parity was estimated in the main cohort, and the joint effect of hysterectomy and vaginal birth or cesarean delivery on stress urinary incontinence surgery was explored in a subgroup of women who only had 1 mode of delivery. All analyses were made using the Cox proportional hazards model. RESULTS: We included 83,370 women who underwent hysterectomy and 413,969 reference women. The overall risk of stress urinary incontinence surgery was more than doubled for women who underwent hysterectomy (adjusted hazard ratio, 2.6; 95% confidence interval, 2.4-2.8). The adjusted hazard ratio decreased slightly to 2.4 (95% confidence interval, 2.3-2.6) when excluding all vaginal hysterectomies. We found a trend of increasing risk of stress urinary incontinence surgery with increased parity among both women who underwent hysterectomy and the reference group. In the subgroup of women who only had 1 mode of delivery, we found the risk of stress urinary incontinence surgery to be particularly increased for women with a history of ≥1 vaginal births. The hazard ratio was 15.1 (95% confidence interval, 10.3-22.1) for women with a history of 1 vaginal birth who underwent hysterectomy, whereas the hazard ratio for women in the reference group with 1 vaginal birth was 5.1 (95% confidence interval, 3.8-8.1). Overall, women who underwent hysterectomy had a 3 times higher risk of stress urinary incontinence surgery than the reference group, irrespective of the number of vaginal births. CONCLUSION: This study indicates, in accordance with previous studies, that hysterectomy increases the risk of subsequent stress urinary incontinence surgery. Women should be informed and gynecologists include this knowledge in decision-making. Further precautions should be taken when treating parous women, particularly those with a history of ≥1 vaginal births.

Hysterectomy on benign indication and risk of pelvic organ prolapse surgery: A national matched cohort study.

INTRODUCTION: Hysterectomy is a frequently performed gynecological procedure but long-term effects remain understudied. Pelvic organ prolapse reduces life quality significantly. The lifetime risk of undergoing pelvic organ prolapse surgery is 20% and parity is known to be the largest risk factor. Studies have shown an increased risk of pelvic organ prolapse surgery after hysterectomy; however, few have studied the compartments which are affected and how this association is affected by surgical route and parity. MATERIAL AND METHODS: In this Danish nationwide cohort study, we identified women born in 1947-2000 who underwent hysterectomy during 1977-2018 who were indexed on the day of hysterectomy. We excluded women who immigrated when older than 15 years, who underwent pelvic organ prolapse surgery prior to index, and who were diagnosed with a gynecological cancer prior to or within 30 days of index. Women who underwent hysterectomy were matched 1:5 to references on age and year of hysterectomy. Women were censored at the time of death, emigration, a gynecological cancer diagnosis, radical or unspecified hysterectomy or December 31, 2018, whichever came first. The risk of pelvic organ prolapse surgery after hysterectomy was computed using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs), adjusted for age, calendar year, parity, income and educational level. RESULTS: We included 80 444 women who underwent hysterectomy and 396 303 reference women. Women who underwent hysterectomy had a significantly higher risk of undergoing pelvic organ prolapse surgery: HRadjusted  1.4 (95% CI 1.3-1.5). In particular, the risk of a posterior compartment prolapse operation was increased: HRadjusted 2.2 (95% CI 2.0-2.3). The risk of prolapse surgery increased with increased parity and by an additional 40% after hysterectomy. Cesarean sections did not seem to increase the risk of prolapse surgery. CONCLUSIONS: This study shows that hysterectomy, regardless of surgical route, leads to an increased risk of pelvic organ prolapse surgery, especially in the posterior compartment. The risk of prolapse surgery increased with the number of vaginal births, and not cesarean sections. Women should be thoroughly informed about the risk of pelvic organ prolapse and other treatment options should be considered before choosing hysterectomy to treat benign gynecological diseases -particularly women who have had numerous vaginal births.

Stress Urinary Incontinence After Operations for Uterine Prolapse: A Nationwide Cohort Study.

IMPORTANCE: Concomitant surgery for stress urinary incontinence (SUI) during pelvic organ prolapse (POP) operations are debated. OBJECTIVES: We aimed to assess the risk of an SUI operation after a uterine prolapse operation and compare the risk after the Manchester procedure versus vaginal hysterectomy. STUDY DESIGN: We performed a nationwide historical cohort study including women with no history of hysterectomy undergoing the Manchester procedure (n = 6065) or vaginal hysterectomy (n = 9,767) for POP during 1998 to 2018. We excluded women with previous surgery for SUI and POP, concomitant surgery for SUI (n = 34, 0.2%), and diagnosed with gynecological cancer before or within 90 days from surgery. Women were followed up until SUI operation/death/emigration/diagnosis of gynecological cancer/December 31, 2018, whichever came first. Women undergoing the Manchester procedure were censored if they had undergone hysterectomy.We assessed the rate of SUI surgery with cumulative incidence plots. We performed Cox Regression to analyze the risk of SUI surgery, adjusting for age, calendar year, income level, concomitant surgery in anterior and posterior compartments, and diagnosis of SUI before POP operation. RESULTS: We found that 12.4% women with and 1.6% without SUI diagnosed before the POP surgery who underwent SUI surgery within 10 years.During follow-up (median, 8.5 years), 129 (2.1%) underwent SUI surgery after the Manchester procedure and 175 (1.8%) after vaginal hysterectomy (adjusted hazard ratio, 1.06 [0.84-1.35]). CONCLUSIONS: Of women diagnosed with SUI before POP operation 1 in 8 subsequently underwent SUI surgery. Few women not diagnosed with SUI subsequently underwent SUI surgery. There was no difference in risk of SUI after the Manchester procedure and vaginal hysterectomy.

Cervical cancer after the Manchester procedure: a nationwide cohort study.

INTRODUCTION AND HYPOTHESIS: The Manchester procedure is a successful operation to treat uterine prolapse. However, the influence on cervical cancer remains unknown. We hypothesized a lower risk of cervical cancer after the Manchester procedure. METHODS: We included all Danish women undergoing the Manchester procedure during 1977-2018 (N = 23,935). Women undergoing anterior colporrhaphy (N = 51,008) were included as references due to comparable health-seeking behaviors. The study cohort is as previously described. We assessed the risk of cervical cancer mortality after the Manchester procedure versus anterior colporrhaphy using cumulated incidence plots and Cox hazard regressions. We applied Fisher's exact test to compare the distribution of histological subtypes after the operations. RESULTS: Generally, few women were diagnosed with cervical cancer (0.1% after Manchester procedure and 0.2% after anterior colporrhaphy). After the Manchester procedure, the risk of cervical cancer was reduced (HR 0.60 [95% CI 0.39-0.94]). Furthermore, we found a slightly reduced risk of overall death (HR 0.96 [95% 0.94-0.99]), but no association regarding death due to cervical cancer (HR 0.66 [95% 0.34-1.25]). The distribution of histological subtypes was not changed. CONCLUSIONS: Women undergoing the Manchester procedure are at lower risk of being diagnosed with cervical cancer, while the risk of cancer specific mortality is unchanged compared to women undergoing anterior colporrhaphy. Based on this study, we cannot recommend that women exit ordinary screening programs for human papillomavirus/cervical dysplasia after a Manchester procedure.

Endometrial cancer after the Manchester procedure: a nationwide cohort study.

INTRODUCTION AND HYPOTHESIS: We aimed to investigate whether the Manchester procedure affects the risk and prognosis of endometrial cancer. METHODS: All Danish residents have a personal number permitting linkage of nationwide registers on the individual level enabling epidemiological studies with lifelong follow-up. We performed a nationwide historical cohort study including Danish women born before 2000 undergoing the Manchester procedure (N = 23,935) during 1977-2018. We included women undergoing anterior colporrhaphy as a reference group (N = 51,008) because of comparable inclination to consult a doctor and clinical similarities. Main outcomes were the number of women diagnosed with endometrial cancer, the stage of endometrial cancer at time of diagnosis, and cancer-specific and overall mortality. We followed the cohort until endometrial cancer/death/emigration/hysterectomy/31 December 2018. We performed chi-square test for trend to compare the diagnostic stage and Cox regressions to analyze the risk of endometrial cancer and mortality. The models were adjusted for age, calendar year, income level, and parity. RESULTS: During follow-up (median 13 years), 271 (1.13%) women were diagnosed with endometrial cancer after the Manchester procedure and 520 (1.05%) after anterior colporrhaphy. The adjusted hazard ratio (HR) for endometrial cancer was 1.00 [95% confidence interval (CI) 0.86-1.16]. No difference in stage of cancer was found (p = 0.18) nor when stratifying for calendar year. The HR for cancer-specific mortality and overall mortality after the Manchester procedure was 0.87 (95% CI 0.65-1.16) and 0.93 (95% CI 0.77-1.12), respectively. CONCLUSIONS: The Manchester procedure does not affect the risk or prognosis of endometrial cancer.

Pelvic organ prolapse following hysterectomy on benign indication: a nationwide, nulliparous cohort study.

BACKGROUND: Hysterectomy is commonly performed and may increase the risk of pelvic organ prolapse. Previous studies in parous women have shown an increased risk of pelvic organ prolapse surgery after hysterectomy. Parity is a strong risk factor for pelvic organ prolapse and may confuse the true relation between hysterectomy and pelvic organ prolapse. OBJECTIVE: This study aimed to investigate whether hysterectomy performed for benign conditions other than pelvic organ prolapse leads to an increased risk of pelvic organ prolapse surgery in a cohort of nulliparous women. STUDY DESIGN: We conducted a historical matched cohort study based on a nationwide population of nulliparous women born in 1947 to 2000 and living in Denmark during 1977 to 2018 (N=549,197). The data were obtained from the Danish Civil Registration System, the Danish National Patient Registry, the Fertility Register, and Statistics Denmark. Women who had a hysterectomy performed in 1977 to 2018 were included in the study (n=9535). For each of these women we randomly retrieved five nonhysterectomized women matched on age and calendar year to constitute the reference group (n=47,370). Cox proportional hazard regression analyses were performed to compare the risk of pelvic organ prolapse surgery in the 2 groups of women. RESULTS: The study included 56,905 women whom we observed for up to 42 years, entailing 809,435 person-years in risk. Overall, 9535 women who underwent a hysterectomy were matched individually with 47,370 reference women. Subsequently, a total of 29 women (30.4%) who underwent a hysterectomy and 85 reference women (17.9%) had a pelvic organ prolapse surgery performed, corresponding to incidence rates of 20.5 and 12.7 per 100,000 risk years, respectively. In addition, the risk of pelvic organ prolapse surgery increased by 60% in women who underwent a hysterectomy compared with women in the reference group (crude hazard ratio, 1.6; 95% confidence interval, 1.0-2.5; P=.04; adjusted hazard ratio, 1.6; 95% confidence interval, 1.0-2.5; P=.04). After the exclusion of women who underwent vaginal hysterectomy and their matches, the results were significantly the same (crude hazard ratio, 1.5; 95% confidence interval, 1.0-2.4; P=.05). Furthermore, we found higher rates of pelvic organ prolapse surgery in women who had a subtotal hysterectomy, total hysterectomy, or vaginal and laparoscopic-assisted vaginal hysterectomies than in women in the reference group. CONCLUSION: Hysterectomy increased the risk of pelvic organ prolapse surgery for nulliparous women by 60%. Previous studies of multiparous women have similarly shown an increased risk of prolapse after hysterectomy. As the most common risk factor for pelvic organ prolapse-vaginal birth-was not included and women were >72 years of age in this study, the numbers of pelvic organ prolapse surgeries were low. Despite the low absolute risk of pelvic organ prolapse surgery in nulliparous women, they were important in investigating the association between hysterectomy and pelvic organ prolapse, excluding vaginal birth, which is the most common risk factor for pelvic organ prolapse. As this cohort study of nulliparous women found an increased risk of pelvic organ prolapse surgery after hysterectomy, it is implied that the uterus per se protects against pelvic organ prolapse. As such, gynecologists should be aware of the risks associated with hysterectomy, and alternative uterus-sparing treatments should be considered when possible. Furthermore, women should be informed about the risks before being offered a hysterectomy.

Surgical repair of vaginal vault prolapse; a comparison between ipsilateral uterosacral ligament suspension and sacrospinous ligament fixation-a nationwide cohort study.

INTRODUCTION AND HYPOTHESIS: Hysterectomy is frequently performed and associated with increased risk of subsequent genital prolapse including vaginal vault prolapse. Ipsilateral uterosacral ligament suspension (IUSLS) and sacrospinous ligament fixation (SSLF) are two commonly performed surgical techniques to treat vaginal vault prolapse. There is no consensus on the ideal operation technique. The aim of this study was to compare IUSLS and SSLF to treat vaginal vault prolapse based on the number of repeat surgeries. METHODS: Previously hysterectomized patients operated on with IUSLS or SSLF in Denmark in 2010-2016 were included in this nationwide register-based cohort study and followed until June 2017. Data were obtained from Danish National Databases, to which reporting is mandatory by law, entailing high validity and completeness of data. Data were analyzed using Cox proportional hazard regression analysis adjusted for age, preoperative prolapse stage, smoking, BMI, and previous prolapse surgery. RESULTS: In total, 744 patients were included; 384 underwent IUSLS while 360 underwent SSLF. After 5 years, 6.5% of patients operated on with IUSLS and 21.8% operated on with SSLF had a repeat surgery in the apical compartment and 12.4% and 30.6% in any compartment, respectively. The risk of repeat surgery was 4.8 times higher after SSLF compared to IUSLS [confidence interval (CI): 2.7-8.4] in the apical compartment and 2.4 times higher (CI: 1.2-5.1) in the anterior compartment. No difference was seen in the posterior compartment. CONCLUSIONS: This study finds significantly higher numbers of repeat surgeries after SSLF compared to after IUSLS in a Danish nationwide cohort.

Evaluation of suture material used in anterior colporrhaphy and the risk of recurrence.

INTRODUCTION AND HYPOTHESIS: The wide variety of suture material used in colporrhaphy shows a lack of consensus on the optimal choice. The evidence guiding the choice of suture material is scant. The aim of this study was to investigate the effects of rapid versus slowly absorbable suture on risk of recurrence after native tissue anterior colporrhaphy. METHODS: This longitudinal cohort study was performed secondary to a previously published study on pelvic organ prolapse recurrence after the Manchester-Fothergill procedure versus vaginal hysterectomy. Data were collected from four Danish databases and corresponding electronic medical records. In this study, women having had anterior colporrhaphy performed were included. Suture materials were divided in three groups: rapid absorbable multifilament suture (RAMuS), rapid absorbable monofilament suture (RAMoS) and slowly absorbable monofilament suture (SAMoS). The main outcome was recurrence of prolapse in the anterior compartment. RESULTS: A total of 462 women were included in this study. No significant difference in recurrence was found among the three suture groups. However, a non-significant tendency towards a higher risk of recurrence in the RAMoS group [HR 2.14 (0.75-6.10) p = 0.16] compared to the RAMuS group was observed. CONCLUSION: In this study, the use of rapid absorbable multifilament suture compared to slowly absorbable monofilament suture does not seem to lead to a higher risk of recurrence after anterior colporrhaphy.

Trends in apical prolapse surgery between 2010 and 2016 in Denmark.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common diagnosis. Today there is no consensus on the ideal operation technique for apical prolapse. Vaginal hysterectomy with suspension of the vaginal cuff is the most frequently used, but the popularity of uterus-preserving techniques is increasing. The aim of this study was to describe trends in surgical techniques used to treat primary apical prolapse in Danish hospitals. METHODS: Data were obtained from the Danish Urogynecological Database and included women with primary prolapse surgery in the apical compartment operated in Denmark 2010-2016. Public hospital departments were divided into three categories according to degree of urogynecological specialization: high level, moderate level, and no specialization. RESULTS: The number of vaginal hysterectomies decreased and the number of uterus-preserving operations increased from 2010 to 2016. The proportion of uterus-preserving techniques versus vaginal hysterectomy differed substantially between different hospital types. At departments with high and moderate levels of specialization, uterus-preserving techniques increased during the period, accounting for nearly 90% and 40%, respectively, in 2016, while decreasing to < 35% for departments with no specialization. Three of the four departments with high-level specialization preferred the Manchester-Fothergill procedure, while one preferred sacrospinous hysteropexy. Only 2.3% of all procedures were performed at private hospitals. CONCLUSIONS: The proportion of uterus-preserving techniques to treat apical prolapse increased from 2010 to 2016. However, there is a wide variation in practice at the different hospitals. An agreement on uterus-preserving techniques has not been reached.

Surgical treatment of primary uterine prolapse: a comparison of vaginal native tissue surgical techniques.

INTRODUCTION AND HYPOTHESIS: Uterine prolapse is a common diagnosis. Today no consensus exists on which operation technique is ideal to treat apical prolapse. Vaginal hysterectomy (VH) with suspension of the vaginal cuff is the most frequently used. The popularity of uterus-preserving techniques is increasing. The aim of this study was to compare the efficiency of vaginal native tissue operations to treat primary apical prolapse, evaluated on risk of relapse surgery. METHODS: Data were obtained from the Danish National Patient Registry (NPR), which contains all operations performed in Denmark. Patients operated on for primary apical prolapse in Denmark 2010-2016 were included and followed until 2017. Clinical data were obtained from the Danish Urogynecological Database. Patients who were previously hysterectomized or operated on for prolapse in the apical compartment were excluded. Data were analyzed using Cox proportional hazard regression analysis and adjusted for age, BMI, smoking, preoperative prolapse stage and previous POP operations. RESULTS: In total, 7247 operations were included. The hazard ratio (HR) for relapse operation in the apical compartment was significantly higher after sacrospinous hysteropexy (SH) compared with the Manchester-Fothergill procedure (MP) [40.2 confidence interval (CI) 21.6-74.7] and VH (8.5 CI: 6.0-12.1). Likewise, the HR was higher in the anterior compartment after SH compared with MP (4.3 CI: 2.9-6.4) and VH (2.8 CI: 2.0-4.0). No convincing difference was found in the posterior compartment. The 5-year reoperation rates were 30%, 7% and 11% after SH, MP, and VH, respectively. CONCLUSIONS: Sacrospinous hysteropexy has exceedingly high numbers of reoperations due to prolapse recurrence.

Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: an activity-based costing analysis.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a common diagnosis that imposes high and ever-growing costs to the healthcare economy. Numerous surgical techniques for the treatment of POP exist, but there is no consensus about which is the ideal technique for treating apical prolapse. The aim of this study was to estimate hospital costs for the most frequently performed operation, vaginal hysterectomy with uterosacral ligament suspension (VH) and the uterus-preserving Manchester-Fothergill procedure (MP), when including costs of postoperative activities. METHODS: The study was based on a historical matched cohort including 590 patients (295 pairs) who underwent VH or MP during 2010-2014 owing to apical prolapse. The patients were matched according to age and preoperative prolapse stage and followed for a minimum of 20 months. Data were collected from four national registries and electronic medical records. Unit costs were obtained from relevant departments, hospital administration, calculated, or estimated by experts. The hospital perspective was applied for costing the resource use. RESULTS: Total costs for the first 20 months after operation were 3,514 € per VH patient versus 2,318 € per MP patient. The cost difference between the techniques was 898 € (95% confidence interval [CI]: 818-982) per patient when analyzing the primary operation only and 1,196 € (CI: 927-1,465) when including subsequent activities within 20 months (p < 0.0001). CONCLUSIONS: The MP is substantially less expensive than the commonly used VH from a 20-month time perspective. Healthcare costs can be reduced by one third if MP is preferred over VH in the treatment of apical prolapse.

The Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: a matched historical cohort study.

INTRODUCTION AND HYPOTHESIS: This study compares vaginal hysterectomy with uterosacral ligament suspension (VH) with the Manchester-Fothergill procedure (MP) for treating pelvic organ prolapse (POP) in the apical compartment. METHODS: Our matched historical cohort study is based on data from four Danish databases and the corresponding electronic medical records. Patients with POP surgically treated with VH (n = 295) or the MP (n = 295) in between 2010 and 2014 were matched for age and preoperative POP stage in the apical compartment. The main outcome was recurrent or de novo POP in any compartment. Secondary outcomes were recurrent or de novo POP in each compartment and complications. RESULTS: The risk of recurrent or de novo POP in any compartment was higher after VH (18.3%) compared with the MP (7.8%) (Hazard ratio, HR = 2.5, 95% confidence interval (CI): 1.3-4.8). Recurrence in the apical compartment occurred in 5.1% after VH vs. 0.3% after the MP (hazard ratio (HR) = 10.0, 95% confidence interval (CI) 1.3-78.1). In the anterior compartment, rates of recurrent or de novo POP were 11.2% after VH vs. 4.1% after the MP (HR = 3.5, 95% CI 1.4-8.7) and in the posterior compartment 12.9% vs. 4.7% (HR = 2.6, 95% CI 1.3-5.4), respectively. There were more perioperative complications (2.7 vs. 0%, p = 0.007) and postoperative intra-abdominal bleeding (2 vs. 0%, p = 0.03) after VH. CONCLUSIONS: This study shows that the MP is superior to VH; if there is no other indication for hysterectomy, the MP should be preferred to VH for surgical treatment of POP in the apical compartment.