Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Pubocervical fascia reconstruction

• Registration Number: NCT05444023
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Anterior colporrhaphy is the commonly performed surgery for pelvic organ prolapse. However the success rates of native tissue repair techniques for anterior vaginal prolapse range from %30-%70. According to a systematic review of the anterior colporrhaphy technique, there was no ideal procedure or guideline for gynecologists to perform. The investigators tried to compare pubocervical fascia suturing techniques with the ideal procedure type by determining step by step all parts of the surgery including the anesthesia type. The aim of the study will be to compare the pubocervical fascia reconstruction techniques in the management of anterior compartment defects (POP-Q \>2) at 1 year and yearly up to 2 years.

Detailed Description

Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international singlecentre single-blind randomized controlled trial by participating in our tertiary referral hospital.

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Study Start: 2022-11-15
• Primary Completion: 2023-11-15
• Status Verified: 2024-03
• Study Completion: 2024-03-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) cystocele
• Women aged between 18-75 years of age

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Exclusion Criteria

• Women not eligible for surgery for medical or anesthesiological reasons
• Inability to comprehend questionnaires
• Inability to give informed consent
• Inability to return for a review
• Prior anterior compartment repair with or without mesh
• Severe cardiovascular or respiratory disease
• Women who don't want anterior compartment repair
• Pregnancy
• Age <18 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
circular continue suturing technique	Pubocervical fascia reconstruction	During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.
Transverse separated suturing technique	Pubocervical fascia reconstruction	During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.

Primary Outcome Measures

Name	Time	Method
Objective success	Time Frame: 12 months after intervention	Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total
Subjective cure rate of prolapse	Time Frame: 12 months after intervention	Provided by the patient's feeling of the "Absence of a bulge in the vagina"

Secondary Outcome Measures

Name	Time	Method
Failure (%)	Time Frame: 12 months after intervention	Recurrence rate
Prolapse-related Quality of life	Time Frame: 12 months after intervention	This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range).; This will also help us in the follow up visits.
Complications	Time Frame: 12 months after intervention	İnjury ( bowel, intestinal, blood vessel injuries)
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	Time Frame: 12 months after intervention	The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.
Incontinence Impact Questionnaire (IIQ-7)	Time Frame: 12 months after intervention	evaluating the impact of urinary incontinence
Pelvic Floor Distress Inventory (PFDI - 20)	Time Frame: 12 months after intervention	evaluating the bowel, bladder, or pelvic symptoms

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey