- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596498
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy in Treatment of Apical Prolapse
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 .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rafael Elkess Gabriel William, Resident
- Phone Number: +201223657844
- Email: rafailogebrael@gmail.com
Study Contact Backup
- Name: Ahmed Farouk, professor
- Phone Number: +201005003309
- Email: drfarouk77@gmail.com
Study Locations
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Abbasia
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Cairo, Abbasia, Egypt
- Recruiting
- Ain Shams University Hospital
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Contact:
- Hisham Arafa, Lecturer
- Phone Number: +201001921334
- Email: Hishamarafa1988@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Laparoscopic Pectopexy
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.
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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.
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Active Comparator: Laparoscopic Sacrocolpopexy
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.
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Laparoscopic Sacrocolpopexy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Assessment
Time Frame: 24 Hours
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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.
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24 Hours
|
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Number of participants treated
Time Frame: 6 Months
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Treatment of the female patients whom suffering from Apical Prolapse using laparoscopic pectopexy and laparoscopic sacrocolpopexy
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6 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmed Farouk, M.D, Professor of Urology Department of Urology Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Apical Prolapse
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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