NCT05252637

Brief Summary

A Randomized Clinical Trial on Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement VS sacral colpopexy isolated for vaginal posterior prolapse

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

February 13, 2022

Last Update Submit

February 13, 2022

Conditions

Pelvic Organ ProlapsePosterior Vaginal Wall Prolapse

Outcome Measures

Primary Outcomes (1)

  • POP-Q

    POP-Q evaluation

    1 year

Study Arms (2)

Duplication plus LSC

EXPERIMENTAL

Laparoscopic duplication of posterior vagina plus mesh placement

Procedure: Laparoscopic Fascial Posterior Vagina Duplication

LSC

NO INTERVENTION

Laparoscopic Sacral Colpopexy with mesh placement on posterior vagina

Interventions

Laparoscopic Fascial Posterior Vagina DuplicationPROCEDURE

Laparoscopic Fascial Posterior Vagina Duplication with absorbable sutures for posterior prolapse (plus standard Sacral Colpopexy)

Duplication plus LSC

Eligibility Criteria

AgeUp to 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Age ≤ 80 years Patient's informed consent American Society of Anesthesiologists: \< class III or IV No previous major abdominal surgical procedures POP-Q stage \> or =III for posterior compartment. No uterine cervix dysplasia or endometrial disorders. No uterine size larger than conform 10 weeks gestation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Pia Fondazione Panico

Tricase, Lecce, 73039, Italy

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea Morciano

    Pia Fondazione Panico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Panico Pelvic Floor Center

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 23, 2022

Study Start

November 1, 2019

Primary Completion

January 20, 2021

Study Completion

January 20, 2022

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

IT(1)