Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
FEMALE
ID07596498

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

Led by Ain Shams University · Updated on 2026-05-19

30

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Apical prolapse, a form of pelvic organ prolapse, commonly affects aging women and significantly impacts quality of life. This condition involves the downward displacement of the vaginal apex, uterus, or vaginal vault and is often accompanied by urinary, bowel, and sexual problems. Researchers are comparing two laparoscopic surgical methods, pectopexy and sacrocolpopexy, to evaluate their effectiveness and learning curves for treating apical prolapse. The study compares laparoscopic pectopexy, a newer technique that uses the iliopectineal ligament for mesh fixation and offers a safer anatomical route with fewer complications, against the traditional laparoscopic sacrocolpopexy, which requires sacral dissection and carries risks such as presacral hemorrhage and nerve injury. About 15 women will undergo laparoscopic pectopexy and another 15 women will have laparoscopic sacrocolpopexy. Both groups will have their pelvic organ prolapse stages evaluated before surgery. Participants will be monitored for pain within 24 hours after surgery and the number of participants treated will be tracked over 6 months. The study involves assessments of anatomical success and safety, focusing on operative time, complications, and learning curves for each procedure. The study is sponsored by Ain Shams University and will enroll women aged 40 to 75 years with apical prolapse requiring surgical treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with uterine prolapse with POP-Q stage 63; III
  • Patients diagnosed with vault vaginal prolapse with POP-Q stage 63; III
Not Eligible

You will not qualify if you...

  • 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 surgery
  • Women with a desire to conceive

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus initial recovery period

Participants undergo laparoscopic pectopexy or laparoscopic sacrocolpopexy surgery to treat apical prolapse and receive immediate post-operative care.

1 surgical visit and immediate post-operative observation

Post-operative Follow-up

Duration - Up to 6 months

Participants attend follow-up visits to assess recovery, pain levels, and the effectiveness of the surgical treatment up to 6 months after surgery.

Multiple follow-up visits during 6 months

Trial Site Locations

Total: 1 location

1

Ain Shams University Hospital

Cairo, Abbasia, Egypt

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Research Team

R

Rafael Elkess Gabriel William, Resident

A

Ahmed Farouk, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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