Laparoscopic Sacropexy: Comparison of Mesh Attachment
Information source: Kantonsspital Aarau
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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
Ending date: June 2014
Last updated: June 24, 2009
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