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Recruiting NCT07306715

NCT07306715 Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.

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Clinical Trial Summary
NCT ID NCT07306715
Status Recruiting
Phase
Sponsor Kocaeli University
Condition Genital Prolapse
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2026-01-29
Primary Completion 2027-04-01

Eligibility & Interventions

Sex Female only
Min Age 40 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Meshless Laparoscopic PectopexyLaparoscopic Pectopexy with mesh

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2026-01-29 with a primary completion date of 2027-04-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.

Eligibility 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

Contact & Investigator

Central Contact

Şener Gezer, M.D.

✉ dr.senergezer@gmail.com

📞 +903723037575

Principal Investigator

İsmail Bıyık, M.D.

STUDY CHAIR

Kütahya Sağlık Bilimleri University

Frequently Asked Questions

Who can join the NCT07306715 clinical trial?

This trial is open to female participants only, aged 40 Years or older, up to 80 Years, studying Genital Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07306715 currently recruiting?

Yes, NCT07306715 is actively recruiting participants. Contact the research team at dr.senergezer@gmail.com for enrollment information.

Where is the NCT07306715 trial being conducted?

This trial is being conducted at Köseköy, Turkey (Türkiye).

Who is sponsoring the NCT07306715 clinical trial?

NCT07306715 is sponsored by Kocaeli University. The principal investigator is İsmail Bıyık, M.D. at Kütahya Sağlık Bilimleri University. The trial plans to enroll 60 participants.

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