Prophylactic Laparoscopic Suspension After McCall

Study Overview
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Brief Summary
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There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.

Detailed Description
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182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum. Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.

Official Title
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Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome

Conditions
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Prolapse Pelvic

Intervention / Treatment
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* Procedure: McCall suture
* Procedure: Standard cuff closure


Participation Criteria
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Eligibility Criteria
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Inclusion criteria LSC simple hysterectomy, Neg. SS test if premenopausal >18j, Consent to participate in the study Understanding of the German language Exclusion criteria Prolapse as indication for surgery Known or suspected non-compliance Additional incontinence procedures Patients with deep infiltrating endometriosis Irradiation pre- or postoperative Pregnancy and lactation. Transgender population Conversion from laparoscopy to laparotomy Inability to understand the study protocol

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McCall suture<br>Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent. | Procedure: McCall suture<br>* Laparoscopic suture including the uterosacral ligaments and the peritoneum<br>* Other names: Uterosacral Ligament Suspension;|
| Sham Comparator: standard cuff closure<br>Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far) | Procedure: Standard cuff closure<br>* Standard laparoscopic barbed suture of the vaginal cuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm. | Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years. Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score | 5 years |