Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pubocervical fascia reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring anterior colporrhaphy, pubocervical fascia, suturing technique, cycstocele, pelvic organ prolapse
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
Sites / Locations
- Kanuni Sultan Suleyman Training and Research HospitalRecruiting
- Kanuni Sultan Suleyman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transverse separated suturing technique
circular continue suturing technique
Arm Description
During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.
During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.
Outcomes
Primary Outcome Measures
Subjective cure rate of prolapse
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
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
Secondary Outcome Measures
Prolapse-related Quality of life
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.
Failure (%)
Recurrence rate
Complications
İnjury ( bowel, intestinal, blood vessel injuries)
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
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)
evaluating the impact of urinary incontinence
Pelvic Floor Distress Inventory (PFDI - 20)
evaluating the bowel, bladder, or pelvic symptoms
Full Information
NCT ID
NCT05444023
First Posted
June 24, 2022
Last Updated
December 3, 2022
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05444023
Brief Title
Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
Official Title
Comparison of Suturing Technique Types on Pubocervical Fascia at Colporrhaphy Anterior for Cystocele Repair
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
anterior colporrhaphy, pubocervical fascia, suturing technique, cycstocele, pelvic organ prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transverse separated suturing technique
Arm Type
Experimental
Arm Description
During pubocervical fascia reconstruction, the surgeon will perform suturing at the transverse plane with an intermittent stitching technique.
Arm Title
circular continue suturing technique
Arm Type
Active Comparator
Arm Description
During pubocervical fascia reconstruction, the surgeon will perform a continuous stitching technique which includes the lateral parts of the anterior compartment defect.
Intervention Type
Procedure
Intervention Name(s)
Pubocervical fascia reconstruction
Intervention Description
Suturing type techniques on pubocervical fascia reconstruction at anterior compartment defects.
Primary Outcome Measure Information:
Title
Subjective cure rate of prolapse
Description
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Time Frame
Time Frame: 12 months after intervention
Title
Objective success
Description
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
Time Frame: 12 months after intervention
Secondary Outcome Measure Information:
Title
Prolapse-related Quality of life
Description
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.
Time Frame
Time Frame: 12 months after intervention
Title
Failure (%)
Description
Recurrence rate
Time Frame
Time Frame: 12 months after intervention
Title
Complications
Description
İnjury ( bowel, intestinal, blood vessel injuries)
Time Frame
Time Frame: 12 months after intervention
Title
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Description
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.
Time Frame
Time Frame: 12 months after intervention
Title
Incontinence Impact Questionnaire (IIQ-7)
Description
evaluating the impact of urinary incontinence
Time Frame
Time Frame: 12 months after intervention
Title
Pelvic Floor Distress Inventory (PFDI - 20)
Description
evaluating the bowel, bladder, or pelvic symptoms
Time Frame
Time Frame: 12 months after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
İstanbul
ZIP/Postal Code
34307
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozan Karadeniz
Phone
2124041500
Email
dr.ozankrdnz@gmail.com
Phone
2124041500
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozan Karadeniz
Phone
2124041500
Email
dr.ozankrdnz@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair
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