Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: LLS versus LP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Lateral Suspension Group (LLS)<br>Anterior and apical prolapse repair via LLS | Procedure: LLS versus LP<br>* Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy<br>|
| Experimental: Laparoscopic Pectopexy (LP)<br>Anterior and apical prolapse repair via LP | Procedure: LLS versus LP<br>* Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | [ Time Frame: 12 months after intervention ] | 
| Failure (%) | Recurrence rate | [ Time Frame: 12 months after intervention ] | 
| Complications | İnjury ( bowel, intestinal, blood vessel injuries, mesh erosions) | [ Time Frame: 12 months after intervention ] | 
| 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. | [ Time Frame: 12 months after intervention ] | 
| Incontinence Impact Questionnaire (IIQ-7) | evaluating the impact of urinary incontinence | [ Time Frame: 12 months after intervention ] | 
| Pelvic Floor Distress Inventory (PFDI - 20) | evaluating the bowel, bladder, or pelvic symptoms | [ Time Frame: 12 months after intervention ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pectopexy, lateral suspension, pelvic organ prolapse, uterine sparing, laparoscopy