Apical ProlapseNCT07596498
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
A study testing Laparoscopic Pectopexy and Laparoscopic Sacrocolpopexy in people with Apical Prolapse, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Apical Prolapse
- What is being tested?
- Laparoscopic Pectopexy and Laparoscopic Sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with uterine prolapse with POP-Q stage ≥ III.
- Patients diagnosed with vault vaginal prolapse with POP-Q stage ≥ III.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo, Abbasia
Hisham Arafa, Lecturer, +201001921334, Hishamarafa1988@gmail.com
About this study
Official title: 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 .
Read the 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.
- Conditions
- Apical Prolapse
- Being tested
- Laparoscopic Pectopexy, Laparoscopic Sacrocolpopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic PectopexyProcedure or 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 SacrocolpopexyProcedure or surgery
Laparoscopic Sacrocolpopexy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Laparoscopic Sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Hours
Number of participants treated
Treatment of the female patients whom suffering from Apical Prolapse using laparoscopic pectopexy and laparoscopic sacrocolpopexy
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Apr 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical ProlapseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafail gebrael, Ain Shams University
- Investigators
- Ahmed Farouk, M.D, Study chair, Professor of Urology Department of Urology Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596498
- Sponsor's protocol ID
- Apical Prolapse
- Status last verified
- Apr 2026
- First submitted
- 10 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy in Treatment of Apical Prolapse
- ClinicalTrials.gov ID
- NCT07596498
- Acronym / sponsor ID
- Apical Prolapse
- Conditions
- Apical Prolapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Pectopexy | Active comparator | Procedure: Laparoscopic PectopexyAbout 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. |
| Laparoscopic Sacrocolpopexy | Active comparator | Procedure: Laparoscopic SacrocolpopexyAbout 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with uterine prolapse with POP-Q stage ≥ III.
- Patients diagnosed with vault vaginal prolapse with POP-Q stage ≥ III.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Pectopexyto 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. | Procedure or surgery | Laparoscopic Pectopexy |
| Laparoscopic SacrocolpopexyLaparoscopic Sacrocolpopexy | Procedure or surgery | Laparoscopic Sacrocolpopexy |
Primary outcome
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.
Number of participants treated
Time frame: 6 Months
Treatment of the female patients whom suffering from Apical Prolapse using laparoscopic pectopexy and laparoscopic sacrocolpopexy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Apical Prolapse
Active, not recruiting
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery
Recruiting
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
RecruitingObservational study
Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Prolapse; Female, Prolapse Uterovaginal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Farouk, M.D study chair
Professor of Urology Department of Urology Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Pectopexy and Laparoscopic Sacrocolpopexy in people with Apical Prolapse, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Elkess Gabriel William, Resident (+201223657844, rafailogebrael@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: 24 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.