A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment; Procedure: laparoscopic sacral colpopexy with posterior mesh attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT04358978

Ospedale "F. Miulli"

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion criteria

• Age > 75 years
• Severe cardiovascular or respiratory disease
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

posterior mesh no attachment

Active Comparator group

Description:

laparoscopic sacral colpopexy with no fixation of posterior mesh

Treatment:

Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment

posterior mesh attachment

Active Comparator group

Description:

laparoscopic sacral colpopexy with fixation of posterior mesh by suture

Treatment:

Procedure: laparoscopic sacral colpopexy with posterior mesh attachment