DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Laparoscopic Sacropexy: Comparison of Mesh Attachment

Information source: Kantonsspital Aarau
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vaginal Vault Prolapse

Intervention: laparoscopic sacropexy with mid vaginal attachment (Procedure); laparoscopic sacropexy with caudal vaginal attachment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Kantonsspital Aarau

Official(s) and/or principal investigator(s):
Dimitri Sarlos, MD, Study Chair, Affiliation: Kantonsspital Aarau, Department of Gynecology and Obstetrics

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.

Clinical Details

Official title: Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of Postoperative Constipation

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- vaginal vault prolapse

- recurrence of vaginal vault prolapse

- signed consent

Exclusion Criteria:

- rectocele

- BMI>40

Locations and Contacts

Kantonsspital Aarau, Aarau, Aargau 5001, Switzerland; Recruiting
LaVonne A Kots, MD, Phone: +41 62 8385027, Email: lavonne.kots@ksa.ch
Dimitri Sarlos, MD, Principal Investigator
LaVonne A Kots, MD, Sub-Investigator
Additional Information

Starting date: June 2009
Last updated: June 24, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017