Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Study Overview
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Brief Summary
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Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.

Official Title
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Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse

Conditions
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Uterine Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic supracervical hysterectomy with sacropexy
* Procedure: Vaginal hysterectomy with uterosacral colposuspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary symptomatic uterine prolapse ≥ 18 years of age Considering pelvic reconstructive surgery Exclusion Criteria: Unwillingness to be randomized to one of two surgical approaches Pregnant or planning to maintain their future fertility Unable to have general anesthesia Currently undergoing chemotherapy OR has current or history of pelvic radiation Previous adverse reaction to synthetic mesh Recent history of abnormal paps (past 10 years) Cervical or uterine cancers Previous hysterectomy Previous central vault or uterine prolapse repair Uterus ≥ 14 weeks size Uterine cancer History of significant pelvic adhesive disease Elongated cervix (length D to C > 6cm) Fibroid ≥ 7cm Post menopausal with enlarged uterus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Repair<br>Laparoscopic supracervical hysterectomy with sacropexy | Procedure: Laparoscopic supracervical hysterectomy with sacropexy<br>* Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it<br>|
| Active Comparator: Vaginal Repair<br>Vaginal hysterectomy with uterosacral colposuspension | Procedure: Vaginal hysterectomy with uterosacral colposuspension<br>* Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL) |  | 24 months | 
| Absence of re-treatment for prolapse at 2 years |  | 24 months | 
| A negative response to Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? | This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in POPQ measurements |  | baseline, 6 week, and 3, 12, and 24 months | 
| Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment | EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire | baseline, 3, 12, and 24 months | 
| Change in patient reported sexual questionnaire, PISQ | PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire | baseline, 3, 12 and 24 months | 
| Frequencies of surgical and post-operative complications | Complications will be classified and reported, based on severity. | up to 2 years post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Prolapse, Laparoscopy, Hysterectomy, vaginal