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

NCT07306715 | Recruiting

• 1 other identifier: KAEK/18.bI.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Prolapse

Keywords

pectopexy; mesh

Outcome Measures

Primary Outcomes (1)

• Apical descensus relapse rate

  The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.

  12 months after surgery

Secondary Outcomes (1)

• Prolapse Quality of Life (P-QOL)

  Preoperative day and 12 months after surgery

Other Outcomes (2)

• De novo central or lateral defect cystocele rate

  12 months after surgery

• De novo rectocele rate

  12 months after surgery

Study Arms (2)

Laparoscopic Pectopexy without mesh

EXPERIMENTAL

In this group of patients, the Laparoscopic Pectopexy operation will be performed without the use of mesh material after hysterectomy. Not using mesh will be protective against possible erosion reactions that may develop in the postoperative period. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.

Procedure: Meshless Laparoscopic Pectopexy

Laparoscopic Pectopexy with mesh

ACTIVE COMPARATOR

In this group of patients, the Laparoscopic Pectopexy operation will be performed using mesh material after hysterectomy. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.

Procedure: Laparoscopic Pectopexy with mesh

Interventions

Meshless Laparoscopic Pectopexy PROCEDURE

The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.

Laparoscopic Pectopexy without mesh

Laparoscopic Pectopexy with mesh PROCEDURE

The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.

Laparoscopic Pectopexy with mesh

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Female patients with symptomatic uterine prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University, School of Medicine

Köseköy, Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Erdem B, Salman S, Usta ZK, Bacak HB, Ozkan MD, Ceken AT, Isik EY, Kumbasar S, Gencer FK, Baghaki HS, Kacar T, Aslan GN, Bulut B. A Novel Approach for Apical Prolapse Surgery: Meshless Pectopexy (Salman's Modification). Int Urogynecol J. 2025 Aug;36(8):1701-1705. doi: 10.1007/s00192-025-06107-z. Epub 2025 Apr 1.

  PMID: 40167602 BACKGROUND

• Aleksandrov A, Smith AV, Rabischong B, Botchorishvili R. Mesh-less laparoscopic treatment of apical prolapse. Facts Views Vis Obgyn. 2021 Jun;13(2):179-181. doi: 10.52054/FVVO.13.2.013.

  PMID: 34184848 BACKGROUND

MeSH Terms

Interventions

Melanocyte-Stimulating Hormones

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• İsmail Bıyık, M.D.

  Kütahya Sağlık Bilimleri University

  STUDY CHAIR

Central Study Contacts

Şener Gezer, M.D.

CONTACT

+903723037575; dr.senergezer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Şener Gezer, MD, Associate Prof., Principal Investigator, Kocaeli University, School of Medicine, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)