Laparoscopic pectopexy with or without mesh after hysterectomy for pelvic organ prolapse
Official title: Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
Run by Kocaeli University · NCT07306715 · Data updated 2026-11-12
This study will test whether laparoscopic pectopexy without mesh works as well as pectopexy with mesh to prevent vaginal cuff prolapse in women who have finished childbearing and choose hysterectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Kocaeli University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Köseköy, Kocaeli) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07306715 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women older than 40 and younger than 80 with symptomatic uterine/apical prolapse (POP-Q stage ≥2) who have completed childbearing and do not want to preserve their uterus are the intended candidates.
✕Probably not a fit
Patients who wish to keep their uterus, are pregnant, have abnormal uterine or cervical bleeding, confirmed genital cancer, or cannot undergo laparoscopic anesthesia are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional study enrolls women with symptomatic apical pelvic organ prolapse (POP-Q stage 2 or higher) who have completed their fertility and do not wish to preserve the uterus. Participants will undergo laparoscopic pectopexy performed either with a polypropylene mesh or using a meshless technique after hysterectomy. Prolapse stage (POP-Q) and quality of life (P-QOL) will be recorded before surgery and again 12 months after surgery, with the main outcome being the proportion of women with stage 2 or greater vaginal cuff prolapse at 12 months. Outcomes will be compared between the mesh and meshless groups to determine differences in anatomical recurrence and patient-reported outcomes.
Why it matters
Potential benefit: If successful, the meshless approach could provide similar prolapse support while reducing the risk of mesh-related complications.
How similar studies have gone: Pectopexy has been reported as a promising alternative to sacrocolpopexy in early series, but direct comparisons of mesh versus meshless pectopexy remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients older than 40 years and younger than 80 years old with symptomatic uterine prolapse * Patients who provided written consent for the surgical procedure * Patients who do not wish to preserve their uterus Exclusion Criteria: * Patients who cannot obtain anesthesia approval for laparoscopic surgery * Patients who have a confirmed or suspected pregnancy * Patients who have abnormal uterine/cervical/vaginal bleeding * Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia * Patients with pathology-confirmed genital cancer * Patients undergone chemotherapy or radiotherapy for any type of cancer
Where it's running
-
Kocaeli University, School of Medicine
Köseköy, Kocaeli, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Şener Gezer, M.D.
- Email: dr.senergezer@gmail.com
- Phone: +903723037575
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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LatGYNious pelvic mesh for treating pelvic organ prolapse
This study will try the LatGYNious preformed mesh during laparoscopic lateral suspension surgery to see if it improves prolapse symptoms in women who need surgical repair.
-
Compare puborectalis plication versus perineorrhaphy (with or without transverse myorrhaphy) to repair vulvovaginal gaping
This trial will test whether one of two surgical repairs better fixes vaginal laxity and improves sexual comfort in sexually active women with prolapse and vulvovaginal gaping.
-
Comparing biological and synthetic mesh in pelvic prolapse surgery
This study is testing whether a new biological mesh works better than the standard synthetic mesh in surgeries for pelvic prolapse to help doctors make better choices for their patients.
-
Using human acellular dermal matrix for treating pelvic organ prolapse in women
This study is testing three different surgical options to see which one works best for women with pelvic organ prolapse.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.