A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

NCT ID: NCT04358978

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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posterior mesh no attachment

laparoscopic sacral colpopexy with no fixation of posterior mesh

Group Type ACTIVE_COMPARATOR

laparoscopic sacral colpopexy with posterior mesh no attachment

Intervention Type PROCEDURE

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

posterior mesh attachment

laparoscopic sacral colpopexy with fixation of posterior mesh by suture

Group Type ACTIVE_COMPARATOR

laparoscopic sacral colpopexy with posterior mesh attachment

Intervention Type PROCEDURE

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

Interventions

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laparoscopic sacral colpopexy with posterior mesh no attachment

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

Intervention Type PROCEDURE

laparoscopic sacral colpopexy with posterior mesh attachment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Miulli General Hospital

OTHER

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Guido

principal investigator, Director of gynaecologic and obstetric department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ospedale regionale Miulli

Acquaviva delle Fonti, Bari, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maurizio Guido

Role: CONTACT

3393894243

Facility Contacts

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Maurizio Guido, PhD

Role: primary

3393894243

Other Identifiers

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Ospedale "F. Miulli"

Identifier Type: -

Identifier Source: org_study_id

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