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Laparoscopic Sacropexy: Comparison of Mesh Attachment

NCT00928239 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2009-06-25

No results posted yet for this study

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.

Conditions

  • Vaginal Vault Prolapse

Interventions

PROCEDURE

laparoscopic sacropexy with mid vaginal attachment

* supracervical hysterectomy for uterine prolapse * exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior * dissection up to ventrolateral part of the levator ani muscle * Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder * Two separate meshes, Gynemesh® (Johnson\&Johnson) a polypropylene mesh, for anterior and posterior compartment * suturing of posterior mesh caudally to levator ani muscle and proximally 4cm from the apex of the vagina or cervical stump * placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex * suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2

PROCEDURE

laparoscopic sacropexy with caudal vaginal attachment

* supracervical hysterectomy for uterine prolapse * exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior * dissection up to ventrolateral part of the levator ani muscle * Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder * Two separate meshes, Gynemesh® (Johnson\&Johnson) a polypropylene mesh, for anterior and posterior compartment * suturing of posterior mesh caudally to the levator ani muscle and proximally at caudal part of the vagina or cervical stump * placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex * suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2

Sponsors & Collaborators

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Dimitri Sarlos, MD · Kantonsspital Aarau, Department of Gynecology and Obstetrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2014-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928239 on ClinicalTrials.gov