Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
LLS versus LP
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pectopexy, lateral suspension, pelvic organ prolapse, uterine sparing, laparoscopy
Eligibility Criteria
Inclusion Criteria:
- Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
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 laparoscopic prolapse repair
- Prior vaginal mesh prolapse procedure
- Severe cardiovascular or respiratory disease
- Women who don't want uterine preserving surgery
- Pregnancy
- Age <18 years, Age >45 years
Sites / Locations
- Kanuni Sultan Suleyman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Laparoscopic Lateral Suspension Group (LLS)
Laparoscopic Pectopexy (LP)
Arm Description
Anterior and apical prolapse repair via LLS
Anterior and apical prolapse repair via LP
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, mesh erosions)
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
NCT05143658
First Posted
October 28, 2021
Last Updated
July 7, 2022
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05143658
Brief Title
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Official Title
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
November 22, 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
The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (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 multicentre single-blind randomized controlled trial with participating 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
pectopexy, lateral suspension, pelvic organ prolapse, uterine sparing, laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Lateral Suspension Group (LLS)
Arm Type
Active Comparator
Arm Description
Anterior and apical prolapse repair via LLS
Arm Title
Laparoscopic Pectopexy (LP)
Arm Type
Experimental
Arm Description
Anterior and apical prolapse repair via LP
Intervention Type
Procedure
Intervention Name(s)
LLS versus LP
Intervention Description
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy
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, mesh erosions)
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
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
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 laparoscopic prolapse repair
Prior vaginal mesh prolapse procedure
Severe cardiovascular or respiratory disease
Women who don't want uterine preserving surgery
Pregnancy
Age <18 years, Age >45 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozan Karadeniz, MD
Phone
+905333663003
Email
dr.ozankrdnz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer Ünal, MD
Phone
+905533888766
Email
dr.omer-unal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozan Karadeniz, MD
Organizational Affiliation
Kanuni Sultan Suleyman Training and Research Hospital
Official's Role
Principal Investigator
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
Email
dr.ozankrdnz@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
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