Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
FEMALE
ID07306715

Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse

Led by Kocaeli University · Updated on 2026-02-02

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical methods for treating genital apical prolapse, a condition where the top of the vagina, uterus, or cervix descends. It focuses on patients who have completed their fertile period and do not want to keep their uterus. The study evaluates laparoscopic pectopexy surgery with and without the use of mesh, a material sometimes linked to complications like mesh erosion, especially in obese patients where surgery is more challenging. Participants will undergo laparoscopic pectopexy surgery after hysterectomy. One group will have the vaginal cuff attached to the pectineal ligament using a non-absorbable suture without mesh, aiming to reduce mesh-related complications. The other group will have the vaginal cuff attached using polypropylene mesh, which is the standard technique. Both surgeries use a standard laparoscopic hysterectomy approach. During the study, patients will have their prolapse stage recorded before surgery and again 12 months after surgery. Quality of life related to prolapse will be assessed using a questionnaire before and one year after the operation. The main outcome measured is the rate of prolapse recurrence 12 months after surgery. Follow-up examinations will be conducted at 12 months post-surgery to evaluate results and safety. Participation lasts at least one year from surgery to follow-up assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients who cannot obtain anesthesia approval for laparoscopic surgery
  • Patients who have a confirmed or suspected pregnancy
  • Patients who have abnormal uterine, cervical, or vaginal bleeding
  • Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia
  • Patients with pathology-confirmed genital cancer
  • Patients who have undergone chemotherapy or radiotherapy for any type of cancer

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo laparoscopic hysterectomy followed by laparoscopic pectopexy, either with or without mesh, to treat pelvic organ prolapse.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - 12 months after surgery

Participants are followed up to assess prolapse status and quality of life after surgery.

1 follow-up visit at 12 months post-surgery

Trial Site Locations

Total: 1 location

1

Kocaeli University, School of Medicine

Köseköy, Kocaeli, Turkey (Türkiye), 41380

Actively Recruiting

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Research Team

Ş

Şener Gezer, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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