Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07306715

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Kocaeli University · Academic / Other
Sex
Female
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREMeshless Laparoscopic PectopexyThe vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
PROCEDURELaparoscopic Pectopexy with meshThe vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.

Timeline

Start date
2026-01-29
Primary completion
2027-04-01
Completion
2027-06-01
First posted
2025-12-29
Last updated
2026-02-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07306715. Inclusion in this directory is not an endorsement.