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

Kocaeli University

Status: Enrolling

Conditions: Genital Prolapse

Treatments: Procedure: Meshless Laparoscopic Pectopexy; Procedure: Laparoscopic Pectopexy with mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT07306715

KAEK/18.bI.02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Laparoscopic Pectopexy without mesh

Experimental group

Description:

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.

Treatment:

Procedure: Meshless Laparoscopic Pectopexy

Laparoscopic Pectopexy with mesh

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopic Pectopexy with mesh