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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-75
SponsorAin Shams University

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic Pectopexy

    Procedure/Surgery

    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/Surgery

    Laparoscopic Sacrocolpopexy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Laparoscopic PectopexyActive comparator 1 intervention
Group B: Laparoscopic SacrocolpopexyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 Hours
2

Number of participants treated

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

Time frame
6 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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