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A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

NCT04358978 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-24

No results posted yet for this study

Summary

This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

laparoscopic sacral colpopexy with posterior mesh no attachment

pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh

PROCEDURE

laparoscopic sacral colpopexy with posterior mesh attachment

pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina

Sponsors & Collaborators

  • Miulli General Hospital

    collaborator OTHER

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Italy

Study Locations

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 NCT04358978 on ClinicalTrials.gov