Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse

Study Overview
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Brief Summary
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Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.

Detailed Description
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This is a single-center, randomized, single-blind surgical trial of women with post-hysterectomy vaginal vault prolapse desiring surgical treatment. The purpose of this study is to compare outcomes of vaginal intraperitoneal uterosacral ligament suspensions and vaginal extraperitoneal uterosacral ligament suspensions for the treatment of post-hysterectomy vaginal vault prolapse. The primary objective will be to compare operative time between the two approaches. Secondary objectives of the trial will be to compare hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches through 12 months using assessments at six weeks, six months, and twelve months. The study will include subjects with stage 1-4 pelvic organ prolapse and descent of the vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2) that desire vaginal surgical management for post-hysterectomy vaginal vault prolapse. Subjects enrolled into the trial will be randomized to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension with a 1:1 allocation using a computer-generated randomization schedule. Patients will be blinded to their allocation. Patients in both groups will receive the same standard of care for vaginal procedures as it currently exists in out practice. This involves the standard anesthetics and opioid medications intraoperatively. Randomization will be revealed to the surgeons in the operating room once the patient is under general anesthesia. Intraoperative data to be collected will include, operative time (minutes from surgical incision time to surgery end time), estimated blood loss (ml), intraoperative complications, and concurrent surgical procedures. Preoperative and postoperative clinical measures to be collected will include POPQ examination points and scores from three validated questionnaires (Pelvic Floor Disability Index (PFDI-20) questionnaire, Pelvic Floor Impact Questionnaires (PFIQ-7) and the Pelvic and Incontinence Sexual Questionnaire (PISQ-12)). Postoperative clinical measures will be collected at six week, six month, and twelve month post-operative visits. Surgical success or failure will be evaluated as a dichotomous composite outcome(objective measures (POPQ examination points) and subjective measures(validated questionnaires) at six week, six month, and twelve month post-operative visits.

Official Title
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Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial

Conditions
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Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal

Intervention / Treatment
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* Procedure: Intraperitoneal Uterosacral Ligament Suspension
* Procedure: Extraperitoneal Uterosacral Ligament Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are 18 years of age or greater English speaking Stage 1 or greater post-hysterectomy vaginal vault prolapse Descent of vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2) Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure Exclusion Criteria: Non-English speaking or not able to provide informed consent Combined surgical cases with other surgical specialties Women unable to follow up postoperatively

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraperitoneal Group<br>Vaginal intraperitoneal uterosacral ligament suspension group | Procedure: Intraperitoneal Uterosacral Ligament Suspension<br>* Vaginal intraperitoneal uterosacral ligament suspension performed by transfixing the ligament, intraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) with three delayed absorbable 0 sutures, performed bilaterally (three sutures per side; six sutures total).<br>|
| Active Comparator: Extraperitoneal Group<br>Vaginal extraperitoneal uterosacral ligament suspension group | Procedure: Extraperitoneal Uterosacral Ligament Suspension<br>* Vaginal extraperitoneal uterosacral ligament suspension performed by transfixing the ligament, extraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) using a suture capturing device with two delayed absorbable 0 sutures, performed bilaterally (two sutures per side; four sutures total).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time (minutes) | Minutes from surgical incision time to surgery end time | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants with surgical success or failure as a dichotomous outcome at the 6 week postoperative visit | Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? or Do you usually experience heaviness or dullness in the pelvic area? in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than not at all to the question How much does this bother you? A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success | 6 week | 
| Percent of participants with surgical success or failure as a dichotomous outcome at the 6 month postoperative visit | Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? or Do you usually experience heaviness or dullness in the pelvic area? in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than not at all to the question How much does this bother you? A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success | 6 month | 
| Percent of participants with surgical success or failure as a dichotomous outcome at the 12 month postoperative visit | Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? or Do you usually experience heaviness or dullness in the pelvic area? in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than not at all to the question How much does this bother you? A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success | 12 month | 
| Hospital length of stay (hours) | Time period between hospital admission and discharge for the surgical encounter | Up to 7 days | 
| Surgical encounter total direct costs ($) | The costs generated by each department of the hospital involved in the surgical patient care, including hospital preoperative, intraoperative, and postoperative costs. This comprises costs related to anesthesia, surgery, operating room, medication, laboratory (including blood transfusion), equipment, and room and board. | Up to 7 days | 
| Estimated blood loss (ml) | Mutual estimation by the surgeon and anesthesiologist | Day of surgery | 
| Frequency of perioperative complications (%) | A perioperative complication will be defined as any documented complication encountered intraoperatively through the sixth postoperative week. Complications include: visceral injury (bowel, bladder, or ureteral), need for blood transfusion, urinary tract infection (defined as patient symptoms with or without a positive urine culture that is treated with antibiotics), wound infection or abscess, readmission, and return to the operating room. | 6 week | 
| Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit | The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 6 week | 
| Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit | The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 6 month | 
| Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit | The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 12 month | 
| Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit | The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 6 week | 
| Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit | The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 6 month | 
| Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit | The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | 12 month | 
| Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. | 6 month | 
| Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. | 12 month | 
| Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery | Postoperative pain is measured by the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable). | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Reconstructive Surgery, Prolapse Surgery