Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Objective success
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ozan Karadeniz
Principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Objective success
Time Frame: 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: Time Frame: 12 months after intervention
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Secondary Outcomes
- Failure (%)(Time Frame: 12 months after intervention)
- Prolapse-related Quality of life(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)
- Pelvic Floor Distress Inventory (PFDI - 20)(Time Frame: 12 months after intervention)