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

NCT05444023 | Completed

• 1 other identifier: KanuniSSEAH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Organ Prolapse

Keywords

anterior colporrhaphy; pubocervical fascia; suturing technique; cycstocele; pelvic organ prolapse

Outcome Measures

Primary Outcomes (2)

• Subjective cure rate of prolapse

  Provided by the patient's feeling of the "Absence of a bulge in the vagina"

  Time Frame: 12 months after intervention

• Objective success

  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

  Time Frame: 12 months after intervention

Secondary Outcomes (6)

• Prolapse-related Quality of life

  Time Frame: 12 months after intervention

• Failure (%)

  Time Frame: 12 months after intervention

• Complications

  Time Frame: 12 months after intervention

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  Time Frame: 12 months after intervention

• Incontinence Impact Questionnaire (IIQ-7)

  Time Frame: 12 months after intervention

Study Arms (2)

Transverse separated suturing technique

EXPERIMENTAL

During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.

Procedure: Pubocervical fascia reconstruction

circular continue suturing technique

ACTIVE COMPARATOR

During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.

Procedure: Pubocervical fascia reconstruction

Interventions

Pubocervical fascia reconstruction PROCEDURE

Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.

Transverse separated suturing technique; circular continue suturing technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (2)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

Location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 5, 2022
• Study Start: November 15, 2022
• Primary Completion: November 15, 2023
• Study Completion: March 3, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

TU (2)