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NCT Number: NCT07596498

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

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 .

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Key information

Conditions

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital

Cairo, Abbasia, Egypt

Location status: Recruiting

Location contact

Hisham Arafa, Lecturer

CONTACT

[email protected]

+201001921334

About this study

Pelvic organ prolapse (POP), particularly apical prolapse, is a prevalent condition that significantly impairs the quality of life in aging women, with a global prevalence ranging from 20% to 65% among those over 50 years of age. It involves the downward displacement of the vaginal apex, uterus, or vaginal vault, and is frequently accompanied by urinary, bowel, and sexual dysfunction. Despite conservative measures, many women with symptomatic POP ultimately require surgical correction to restore pelvic anatomy and function.

Multiple surgical techniques have been developed for apical suspension, including transvaginal approaches (e.g., sacrospinous fixation, high uterosacral ligament suspension), transabdominal techniques, and laparoscopic modalities. Among laparoscopic approaches, sacrocolpopexy (LSC) has long been considered the gold standard due to its superior anatomical outcomes compared to native tissue repair or vaginal mesh-based procedures.

However, it demands advanced laparoscopic skills, has a steep learning curve, and carries a risk of complications such as presacral hemorrhage, mesh erosion, defecation dysfunction, and sacral osteomyelitis.

Laparoscopic sacrocolpopexy involves dissection at the sacral promontory and mesh fixation to the anterior longitudinal ligament. Although it provides excellent long-term anatomical support-with reported objective success rates between 78% and 100%-it is associated with longer operative time and potential injuries to the ureter, bowel, or vessels. Furthermore, the anatomical challenges posed by the sacral promontory, especially in obese patients, can hinder operative safety and efficiency.

Laparoscopic pectopexy, first described by Banerjee and Noé in 2011, is an emerging alternative technique in which the mesh is bilaterally anchored to the iliopectineal (Cooper's) ligaments. This anterior fixation avoids dissection near critical retroperitoneal structures and preserves the posterior pelvic space, thereby reducing the risk of defecation disorders and nerve injury. Pectopexcy an emerging technique offers a potential alternative for apical prolapse repaire .this study aims to compare its efficacy &safety with conventional procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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 sacrocolpopexy

Procedure

Laparoscopic Sacrocolpopexy

Primary outcomes

  1. Pain Assessment

    Time frame: 24 Hours

    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.

  2. Number of participants treated

    Time frame: 6 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Farouk, professor

CONTACT

[email protected]

+201005003309

Rafael Elkess Gabriel William, Resident

CONTACT

[email protected]

+201223657844

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy in Treatment of Apical Prolapse

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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