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

NCT ID: NCT07306715

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-01

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.

Detailed Description

After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.

Conditions

Genital Prolapse

Keywords

pectopexy; mesh

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laparoscopic Pectopexy without mesh

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.

Group Type: EXPERIMENTAL

Meshless Laparoscopic Pectopexy

Intervention Type: PROCEDURE

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

Laparoscopic Pectopexy with mesh

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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Pectopexy with mesh

Intervention Type: PROCEDURE

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

Interventions

Meshless Laparoscopic Pectopexy

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

Intervention Type: PROCEDURE

Laparoscopic Pectopexy with mesh

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Şener Gezer

Şener Gezer, MD, Kocaeli University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İsmail Bıyık, M.D.

Role: STUDY_CHAIR

Kütahya Sağlık Bilimleri University

Central Contacts

Şener Gezer, M.D.

Role: CONTACT

Phone: +903723037575

Email: dr.senergezer@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 40167602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34184848 (View on PubMed)

Other Identifiers

KAEK/18.bI.02

Identifier Type: -

Identifier Source: org_study_id