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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05444023
Collaborator
(none)
60
1
2
24.5
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pubocervical fascia reconstruction
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transverse separated suturing technique

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

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

Active Comparator: circular continue suturing technique

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

Outcome Measures

Primary Outcome Measures

  1. 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"

  2. 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

Secondary Outcome Measures

  1. 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.

  2. Failure (%) [Time Frame: 12 months after intervention]

    Recurrence rate

  3. Complications [Time Frame: 12 months after intervention]

    ─░njury ( bowel, intestinal, blood vessel injuries)

  4. 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.

  5. Incontinence Impact Questionnaire (IIQ-7) [Time Frame: 12 months after intervention]

    evaluating the impact of urinary incontinence

  6. Pelvic Floor Distress Inventory (PFDI - 20) [Time Frame: 12 months after intervention]

    evaluating the bowel, bladder, or pelvic symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanuni Sultan Suleyman Training and Research Hospital ─░stanbul Turkey 34307

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05444023
Other Study ID Numbers:
  • KanuniSSEAH
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022