Comparison of Mesh-Based and Mesh-Free Laparoscopic Pectopexy in Uterus-Preserving Surgery for Apical Prolapse

NCT ID: NCT07080957

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2025-07-14

Brief Summary

This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Key outcomes assessed included operative time, blood loss, hospital stay, anatomical correction (POP-Q), sexual function (PISQ-12), and complications. Both techniques significantly improved prolapse and sexual function. Mesh-based pectopexy offered superior apical and posterior support, while mesh-free pectopexy was associated with longer vaginal length and longer operative time. Complication and recurrence rates were low and similar across groups. The findings suggest that both techniques are effective, and surgical approach should be tailored to patient preference and clinical context.

Detailed Description

This retrospective cohort study was conducted to compare the anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in the treatment of apical pelvic organ prolapse (POP). POP is a common condition among women, particularly those over 50 years of age, characterized by the descent of pelvic organs into the vaginal canal. While mesh-based procedures are known to offer robust apical support, they are associated with long-term complications such as mesh erosion, infection, and chronic pelvic pain. In contrast, mesh-free techniques may offer a safer alternative, particularly for patients wishing to avoid synthetic implants.

A total of 81 patients who underwent laparoscopic pectopexy between 2021 and 2024 at a tertiary care institution were included. Patients were divided into two groups based on the use of mesh: 41 underwent mesh-based and 40 underwent mesh-free procedures. Preoperative and postoperative assessments were conducted using the POP-Q (Pelvic Organ Prolapse Quantification) system for anatomical staging and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) for evaluating sexual function. Operative time, estimated blood loss, length of hospital stay, postoperative complications, and recurrence rates were also analyzed. Follow-up evaluations were scheduled at 6 weeks, 3 months, and 1 year.

The study found that both techniques significantly improved anatomical support and sexual function. Mesh-based pectopexy provided better apical and posterior compartment support, while the mesh-free approach resulted in a longer vaginal length and was preferred by patients seeking to avoid mesh-related complications. Operative time was significantly longer in the mesh-free group. Complication and recurrence rates were low and comparable between groups.

This study contributes to the growing body of evidence supporting uterus-preserving surgical options in POP treatment and highlights the importance of individualized surgical planning based on patient needs, preferences, and clinical profiles.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesh-free laparoscopic uterus-preserving pectopexy

Patients in this group underwent laparoscopic uterus-preserving pectopexy without the use of synthetic mesh. Instead, native tissue fixation techniques were employed to achieve apical support. The uterus was preserved in all cases. Follow-up was conducted at 6 weeks, 3 months, and 1 year to evaluate outcomes.

Group Type: ACTIVE_COMPARATOR

Mesh-free laparoscopic uterus-preserving pectopexy

Intervention Type: PROCEDURE

Laparoscopic pectopexy without synthetic mesh was performed by utilizing native tissue fixation techniques. The uterus was suspended to the iliopectineal ligaments using permanent sutures without mesh implantation. The procedure aimed to provide apical support and avoid mesh-related complications. Postoperative follow-up included assessments of anatomical correction, functional recovery, and patient satisfaction.

Mesh-based laparoscopic uterus-preserving pectopexy

Patients in this group underwent laparoscopic uterus-preserving pectopexy using synthetic mesh for apical support. The mesh was fixed bilaterally to the iliopectineal ligaments to restore apical support while preserving the uterus. Outcomes were assessed preoperatively and at 6 weeks, 3 months, and 1 year postoperatively.

Group Type: ACTIVE_COMPARATOR

Mesh-based laparoscopic uterus-preserving pectopexy

Intervention Type: PROCEDURE

Laparoscopic pectopexy was performed using a synthetic mesh to provide apical support while preserving the uterus. The mesh was bilaterally fixed to the iliopectineal (Cooper's) ligaments, and the uterus was suspended in a tension-free manner. This technique is designed to restore pelvic anatomy and improve symptoms of prolapse. Patients were followed postoperatively to assess anatomical success, complications, and functional outcomes.

Interventions

Mesh-free laparoscopic uterus-preserving pectopexy

Laparoscopic pectopexy without synthetic mesh was performed by utilizing native tissue fixation techniques. The uterus was suspended to the iliopectineal ligaments using permanent sutures without mesh implantation. The procedure aimed to provide apical support and avoid mesh-related complications. Postoperative follow-up included assessments of anatomical correction, functional recovery, and patient satisfaction.

Intervention Type: PROCEDURE

Mesh-based laparoscopic uterus-preserving pectopexy

Laparoscopic pectopexy was performed using a synthetic mesh to provide apical support while preserving the uterus. The mesh was bilaterally fixed to the iliopectineal (Cooper's) ligaments, and the uterus was suspended in a tension-free manner. This technique is designed to restore pelvic anatomy and improve symptoms of prolapse. Patients were followed postoperatively to assess anatomical success, complications, and functional outcomes.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of pelvic organ prolapse (POP) classified as stage 2 or higher according to the POP-Q (Pelvic Organ Prolapse Quantification) system
• Desire for uterus preservation and refusal of hysterectomy during surgery
• Eligible for surgical intervention and able to undergo general anesthesia
• Women aged 18 years and older with pelvic organ prolapse

Exclusion Criteria

• History of hysterectomy
• Severe comorbidities (e.g., serious cardiovascular diseases, bleeding disorders, or other medical conditions that may interfere with surgical treatment)
• Active infections in the pelvic or urogenital region
• Advanced malignancies (e.g., cancer)
• Psychological or cognitive impairments preventing informed consent or compliance with postoperative follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Havva Betül Bacak

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Betül Bacak

Specialist in Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

enes serhat coşkun, md

Role: STUDY_CHAIR

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Locations

Gaziosmanpaşa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

gopMeshBasedMeshFreepecto

Identifier Type: -

Identifier Source: org_study_id