CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
tunneling +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02856217
NCT02856217N/ACompleted

Comparison of the Tunneling or Non-tunneling During Minimally Invasive Sacrocolpopexy in Terms of Lower Urinary Tract and Bowel Symptoms.

The University of Texas Medical Branch, Galveston·interventional·Posted Aug 4, 2016·Updated Oct 10, 2019

In Brief

A clinical study evaluating tunneling and non-tunneling for Lower Urinary Tract Symptoms and Lower Gastrointestinal Tract Symptoms. Completed, enrolled 60 participants.

Detailed Summary

Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic organ prolapse and serves as the criterion standard against which other operations are compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000 surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is known about safety and long-term effectiveness. Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for pelvic organ prolapse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 4, 2016
Enrollment StartAug 1, 2016
Primary CompletionSep 1, 2017
Study CompletionSep 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.9 years ago

Interventions

tunnelingprocedure

In this arm of the study which is Peritoneal tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (creating a tunnel between vaginal apex and sacrum under peritoneum without disturbing the integrity of the peritoneum)

non-tunnelingprocedure

In this arm of the study which is Peritoneal non-tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (incised and sutured peritoneum between vaginal apex and sacrum).