Laparoscopic Sacropexy: Comparison of Mesh Attachment

Not Applicable

• Conditions: Vaginal Vault Prolapse
• Interventions: Procedure: laparoscopic sacropexy with mid vaginal attachment; Procedure: laparoscopic sacropexy with caudal vaginal attachment

• Registration Number: NCT00928239
• Lead Sponsor: Kantonsspital Aarau

Brief Summary

The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

Detailed Description

Laparoscopic sacropexy has become a well established treatment option for vaginal vault prolapse with excellent outcome and low rates of recurrence. Compared to the similar vaginal sacropexy procedure a significant rate of postoperative constipation is reported. As the surgical technique is very similar for both procedures it could be possible that the exposure of the lower vaginal wall and placement and of the dorsal mesh and closer proximity to the colon in laparoscopic sacropexy might cause this. In this randomized controlled clinical trial we compare two different attachment sites for the dorsal mesh during laparoscopic sacropexy. One group is randomized for attachment in the middle of the dorsal wall of the vaginal stump and for the other group preparation and attachment for the dorsal mesh is performed deeper in the lower pelvis for an attachment at the distal part of the dorsal vaginal wall.

Peri-operative data, intra- and postoperative complications and results of short-term (constipation) and long-term( recurrences rate) outcome are recorded.

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Last Update Submitted: 2009-06-24
• Study First Posted: 2009-06-25
• Last Update Posted: 2009-06-25
• Primary Completion: 2011-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• vaginal vault prolapse
• recurrence of vaginal vault prolapse
• signed consent

Exclusion Criteria

• rectocele
• BMI>40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	laparoscopic sacropexy with mid vaginal attachment	Arm1: Laparoscopic repair of vaginal vault prolapse. Laparoscopic sacropexy procedure as described in previous publication(Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol JPelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. Epub 2008 Jun 7. PubMed PMID: 18536861) with attachment to the caudal part of the vagina and the apex.
2	laparoscopic sacropexy with caudal vaginal attachment	Arm 2: Laparoscopic repair of vaginal vault prolapse. Laparoscopic sacropexy procedure as described in previous publication(Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol JPelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. Epub 2008 Jun 7. PubMed PMID: 18536861) with attachment of the dorsal mesh at distal end of vagina at dorsal vaginal wall

Primary Outcome Measures

Name	Time	Method
Rate of Postoperative Constipation	6 to 8 weeks postoperatively

Trial Locations

Locations (1)

Kantonsspital Aarau; 🇨🇭 Aarau, Aargau, Switzerland