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

Official title

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

Overview

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.

Interventions

• Procedure Meshless Laparoscopic Pectopexy
  The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
• Procedure Laparoscopic Pectopexy with mesh
  The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.

Primary outcome measures

• Apical descensus relapse rate [Time frame: 12 months after surgery]

Secondary outcome measures (1)

• Prolapse Quality of Life (P-QOL) [Time frame: Preoperative day and 12 months after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kocaeli University, School of Medicine — Köseköy

Publications

• 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
• 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

Identifiers

NCT: NCT07306715 · KAEK/18.bI.02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗