Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

Study Overview
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Brief Summary
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Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%. The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall. A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length. From the literature review to date, no comparisons were made between the methods in a randomized controlled trial. Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF

Detailed Description
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Pelvic organ prolapse (POP) is a common problem among women and its incidence is rising due to population aging. Approximately 11-19% of women will undergo surgery for pelvic organ prolapse (POP) or urinary incontinence during their lifetime and approximately 30% will need repeat surgery during their lifetime .Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. The severity of the prolapsed organ can be graded according to the POP-Q classification .There are several approaches to apical fixation, some of which are done vaginally and include fixation by sutures to the uterosacral ligament (USLF) or the sacrospinous ligament (SSLF). A mesh can be used for ligament fixation as well. The abdominal approach is also an option, the sacro-colpo-pexy fixation using a Y mesh. Apical fixation to the SSL was first introduced in 1968 by K.RICHTER. medical devices such as the Capio that assist in performing SSLF were also developed with ease. In a review article that included 2,390 women undergoing SSLF subjective cure rate ranged from 70 to 98%, while objective cure rate was 67-97% .Such fixation in combination with posterior or anterior wall repair, especially after hysterectomy, showed a 94% objective cure rate at 7-year postoperative follow-up. A randomized study (The OPTIMAL randomised trial) comparing SSLF with USLF found no preference for either method. Success rates were measured according to three criteria - 1) no significant vaginal dome or one of the vaginal walls 2) no vaginal bulge symptoms 3) no need for repeated surgery within two years of the original surgery. According to this study, the success rates of SSLF after two years were 63.1%. Among women with anterior vaginal wall prolapse and AP, SSLF can be performed in two ways: anterior access, ie dissection through the anterior wall of the vagina or fixation through the posterior wall of the vagina. A retrospective comparison of the two methods was performed, demonstrating some efficacy in anterior approach in terms of vaginal length and postoperative apical fixation with less reference to healing rates or impact on the anterior compartment, compared with a posterior approach. From the literature review to date, no comparisons were made between the methods in a randomized controlled trial. Objective: To compare the success rates of two approaches (anterior and posterior) for SSLF

Official Title
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Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse, Surgical Procedure, Unspecified

Intervention / Treatment
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* Procedure: Apical prolapse fixation - anterior access
* Procedure: Apical prolapse fixation - posterior access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse. Women who suffer from symptomatic POP and care for a surgical treatment Exclusion Criteria: Women with a contra-indication for surgical treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anterior approach for apical fixation to the SSL<br>In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall. | Procedure: Apical prolapse fixation - anterior access<br>* The surgery is done in anterior access<br>|
| Active Comparator: posterior approach for apical fixation to the SSL<br>In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall. | Procedure: Apical prolapse fixation - posterior access<br>* The surgery is done in posterior access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compound cure rate | A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up): A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response (no or not at all to the question, Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment | 6-month (and will be further followed yearly until 2 years of total follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Duration of surgery in minutes | From the time of the first cut of the surgery to the time the surgery ends (as documented in the surgery report), up to 240 minutes | 
| Change in hemoglobin level from pre-operation level to post-operative level in g/dl units | to assess the difference in Hb level before and after the surgery | Hb level will be measured up to 1 month before the surgery and at the 24 hours after surgery. Further examinations will be taken if there is clinical suspicious for bleeding, up to the day of discharge) | 
| Intraoperative complications | Any documented event of perforation of adjacent organs such as bladder, ureter, intestine or blood vessel injury that occured during the surgery | Any complication the occured during the duration of the surgery | 
| Peri-operative complications | Any event of fever / abnormal discharge / abscess / contaminated hematoma/ need for blood transfusion | Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery) | 
| Maximal pain score | To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). the investigators will assess the maximum pain level during the 6 weeks after the surgery | Maximal pain level during the 6 weeks after the surgery | 
| Change in PFDI-20 score | Mean scores and change from baseline of PFDI-20 score at 6 and 12, 24 months. To evaluate prolapse, urinary and bowel function(PFDI-20). | 6, 12 and 24 months post the operation | 
| Patient global impression of improvement from surgery | Mean scores of PGI-I at 6 and 12, 24 months. To evaluate patient satisfaction from the surgery. | 6, 12 and 24 months post the operation | 
| Cure rate at 12 months post-operation | A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 12-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response (no or not at all to the question, Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment | 12 months post the operation | 
| Cure rate at 24 months post-operation | A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 24-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response (no or not at all to the question, Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment | 24 months post the operation | 
| long term complications | Incidence of new-onset dyspareunia; de-novo urinary or bowel problems; re-operation for prolapse in the index compartment; de-novo pelvic pain. | 6, 12 and 24 months post the operation |