Laparoscopic pectopexy with or without mesh after hysterectomy for pelvic organ prolapse
Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Female |
| Sponsor | Kocaeli University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Köseköy, Kocaeli) |
| Trial ID | NCT07306715 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Pectopexy has been reported as a promising alternative to sacrocolpopexy in early series, but direct comparisons of mesh versus meshless pectopexy remain limited.
Eligibility criteria
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 this trial is running
Köseköy, Kocaeli
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.