MedTrace Logo

Impact of Tunneling During Minimally Invasive Sacrocolpopexy

NCT02856217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-10

No results posted yet for this study

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.

Conditions

  • Lower Urinary Tract Symptoms
  • Lower Gastrointestinal Tract Symptoms

Interventions

PROCEDURE

tunneling

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)

PROCEDURE

non-tunneling

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).

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Gokhan S Kilic, MD · UTMB, Texas

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2018-09-25

More Related Trials

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 NCT02856217 on ClinicalTrials.gov