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Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

NCT02852512 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-08-04

No results posted yet for this study

Summary

The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

sacrocolpopexy

Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Elisabetta Costantini, MD · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2018-03-31

Countries

  • Italy

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 NCT02852512 on ClinicalTrials.gov