Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

Study Overview
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Brief Summary
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The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period. Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment. Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure. EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)

Detailed Description
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All patients will be operated by the same surgeon. Antibiotic prophylaxis will be given pre-operatively according hospital protocols 30 minute before surgery. Surgery will be performed under general anesthesia in the lithotomy position with legs in stirrups The following peri-operative and patient data will be collected and analyzed: preoperative POP- Q, body mass index (BMI), age, parity, history of vaginal delivery, previous pelvic surgery, total operating time, estimated bloodloss, serum hemoglobin (Hb) drop (change between preoperative Hb and postoperative Hb 1 day after surgery), peri-operative complications, post- operative pain score and POP-Q after 6 and 12 months. The ICIQ-LUTSqol questionnaire (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) is a psychometrically robust patient- completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients with particular reference to social effects. It has 20 items to response with overall score between 19- 76 indicating increased impact on quality of life with greater values. Subjective surgical outcome was measured using the Patient Global Impression of Improvement (PGI-I), which is a validated tool as a global index of response to prolapse surgery. The PGI-I is a seven-scale response for women comparing the postoperative condition with the pre-operative state, 1 being very much better and 7 being very much worse. The women's prolapse symptoms and their impact will be evaluated before surgical treatment. A subjective assessment of the prolapse was made using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) before and 12 months after treatment. The PISQ-IR is designed as a condition-specific measure of sexual function in women with pelvic floor dysfunction, including urinary and anal incontinence and pelvic organ prolapse. It consists on 18-21 questions depending weather respondent indicates having a sexual partner or not. The cutoff score of 2.68 for PISQ-IR Summary Score allowed to diagnose sexual dysfunction in sexually active women with pelvic floor disorders. Pelvic floor ultrasound will be performed before the operation and at 6 and 12 months after the operation. The inspection methods are as follows: Before the inspection, patients emptied the stool and moderately filled the bladder. The following parameters will be measured in resting state using the maximal Valsalva maneuver: Posterior vesicourethral angle (PVA):This included the angle between the proximal urethra and posterior wall of the bladder. Urethral tilt angle: This included the angle between the proximal urethra and vertical axis of the human body. Value is negative if the urethral axis deviated to the ventral side, and the value was positive when it is deviated to the dorsal side. Postoperative rotation angle of the urethra (UR): This refers to the difference in PVA between the Valsalva state and resting state. Bladder neck descent (BND): This refers to the vertical displacement of the bladder neck between the Valsalva state and resting state.

Official Title
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COMPARISON BETWEEN AUTOLOGOUS TISSUE RECONSTRUCTION USING vNOTES AND TRADITIONAL SURGERY IN TREATMENT OF PELVIC ORGAN PROLAPSE

Conditions
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Vaginal Vault Prolapse

Intervention / Treatment
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* Procedure: vNOTES suspension with autologous tissue
* Procedure: Vaginal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 18 years old with no desire to preserve fertility, POP-Q 3 or 4 stage of prolapse with indication for hysterectomy (abnormal uterine bleeding, enlarged fibrous uterus, premalignant cervical findings) Exclusion Criteria: Virginity, pregnancy, acute urinary infection were considered contraindications; malignancy, previous PID or rectal surgery. Rectovaginal endometriosis. Contraindication for general anaesthesia, pneumoperitoneum or Trendelenburg position. Previous pelvic radiotherapy

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: In one group of patients vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Second group will be treated with minimally invasive technique (vNOTES-vaginal natural orifice transluminal surgery) in which we will remove uterus and support pelvic floor with autologous tissue. Tissue graft will be isolated from abdominal rectus muscle. Fixation will be done using vNOTES aproach.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional surgery<br>This group of patients will be treated with standard technique (vaginal hysterectomy with anterior and/or posterior vaginal repair) for pelvic organ prolapse . | Procedure: Vaginal surgery<br>* Vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Uterosacral and cardinal ligaments will be repositioned and attached to the vaginal vault after hysterectomy at the time of vault closure. A modified McCall culdoplasty will be done in this group to prevent enterocele and further apical prolapse<br>|
| Active Comparator: vNOTES PREFAP<br>This group of patients will be treated with vNOTES aproach using autologous graft isolated from posterior rectus fascia for pelvic organ prolapse. | Procedure: vNOTES suspension with autologous tissue<br>* Autologous tissue will be fixated on solid points in pelvis using vNOTES.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional surgery vrs vNOTES PREFAP | Compare the efficacy of vNOTES autograft repair and traditional surgery between the two groups by determining the risk of reoperation for anterior, posterior or apical prolapse within the study period | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Diagnosis of an autologous tissue or vNOTES-associated complication. | 1 year | 
| QoL | Compare quality of life in both groups before operation and 6 months after procedure using ICIQ-LUTSqol questionnaire | 1 year | 
| Subjective pelvic floor outcomes | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used before and 12 months after treatment to compare subjective impression of procedure | 1 year | 
| Ultrasound measurement | Objective evaluation of the effect of postoperative results using transperineal ultrasound before operation, 6 and 12 months after procedure | 1 year | 
| Learning curve | To assess the learning curve of harvesting the PREFAP autologous tissue measuring time and complications | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous graft, vNOTES, Pelvic organ prolapse