Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy

NCT07596498 | Recruiting DMC

• 1 other identifier: Apical Prolapse
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic organ prolapse, particularly apical prolapse, is a common condition among aging women, and laparoscopic sacrocolpopexy is considered the standard surgical treatment due to its high anatomical success. However, it poses technical challenges and risks related to sacral dissection. Laparoscopic pectopexy, a newer technique using the iliopectineal ligament for mesh fixation, offers a safer anatomical route with shorter operative time and fewer complications. The previous studies evaluate the sacrocolpopexy and pectopexy are all retrospective. This study is prospective randomized controlled study that adds Comparison on the success rate and learning curve of pectopexy versus sacrocolpopexy .

Conditions

Apical Prolapse

Outcome Measures

Primary Outcomes (2)

• Pain Assessment

  To assess the Pain intensity after the operation and the pain will be evaluated using the Visual Analog Scale (VAS) whereas : 0 is no pain, and 10 is worst pain.

  24 Hours

• Number of participants treated

  Treatment of the female patients whom suffering from Apical Prolapse using laparoscopic pectopexy and laparoscopic sacrocolpopexy

  6 Months

Study Arms (2)

Laparoscopic Pectopexy

ACTIVE COMPARATOR

About 15 women patients suffering from apical prolapse and will undergo Laparoscopic Pectopexy and The Pelvic Organ Prolapse Quantification (POP-Q) stages will be evaluated preoperatively.

Procedure: Laparoscopic Pectopexy

Laparoscopic Sacrocolpopexy

ACTIVE COMPARATOR

About 15 women patients suffering from apical prolapse and will undergo Laparoscopic Sacrocolpopexy.and The Pelvic Organ Prolapse Quantification (POP-Q) stages will be evaluated preoperatively.

Procedure: Laparoscopic Sacrocolpopexy

Interventions

Laparoscopic Pectopexy PROCEDURE

to evaluate the effectiveness and learning curve of laparoscopic pectopexy in comparison with laparoscopic sacrocolpopexy for the treatment of apical prolapse performed by the same surgeon.

Laparoscopic Pectopexy

Laparoscopic Sacrocolpopexy PROCEDURE

Laparoscopic Sacrocolpopexy

Laparoscopic Sacrocolpopexy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with uterine prolapse with POP-Q stage ≥ III.
• Patients diagnosed with vault vaginal prolapse with POP-Q stage ≥ III.

You may not qualify if:

• Patients who refuse to participate in the study.
• Patients who have isolated anterior or posterior vaginal wall prolapse.
• Women who are pregnant or lactating.
• Patients with severe comorbidities, including: Serious heart, liver, kidney, or blood diseases or any condition preventing them from tolerating surgery.
• Women with a desire to conceive.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Abbasia, Egypt

RECRUITING

Study Officials

• Ahmed Farouk, M.D

  Professor of Urology Department of Urology Ain Shams University

  STUDY CHAIR

Central Study Contacts

Rafael Elkess Gabriel William, Resident

CONTACT

+201223657844; rafailogebrael@gmail.com

Ahmed Farouk, professor

CONTACT

+201005003309; drfarouk77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Urology Department

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

EG (1)