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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McCall suture | Experimental | Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent. |
|
| standard cuff closure | Sham Comparator | Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McCall suture | Procedure | Laparoscopic suture including the uterosacral ligaments and the peritoneum |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score | 5 years |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Höhn, MD | Contact | 0316321010 | 0316321010 | diana.hoehn@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Michel D Mueller, Prof. | Department of Gynaecology, University Hospital, Berne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsfrauenklink Inselspital | Recruiting | Bern | 3010 | Switzerland |
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| Standard cuff closure | Procedure | Standard laparoscopic barbed suture of the vaginal cuff |
|