Laparoscopic Sacropexy: Comparison of Mesh Attachment (MeshPlace)

Kantonsspital Aarau

Status: Unknown

Conditions: Vaginal Vault Prolapse

Treatments: Procedure: laparoscopic sacropexy with mid vaginal attachment; Procedure: laparoscopic sacropexy with caudal vaginal attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT00928239

KSA-MeshPlace

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• rectocele
• BMI>40

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: laparoscopic sacropexy with mid vaginal attachment

2

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic sacropexy with caudal vaginal attachment