0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

Study Overview
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Brief Summary
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VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.

Detailed Description
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The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

Official Title
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Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse

Conditions
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Vaginal Prolapse

Intervention / Treatment
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* Procedure: VNOTES/VH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with vaginal prolapse capable of having a surgery - assessed by an anesthesiologist women who approve of having the surgery Exclusion Criteria: BMI over 40 women who have recurrent PID (pelvic inflammatory disease) women with oncology records

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: VNOTES ARM<br>treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments. | Procedure: VNOTES/VH<br>* same as above<br>|
| Experimental: Vaginal hysterectomy Arm<br>treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments. | Procedure: VNOTES/VH<br>* same as above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery time | time of surgery | from admission up to 6 hours post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding | bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation. | from admission up to 6 hours post operation | 
| hospital days | how many days after surgery for hospitalization | from admission up to 96 hours post operation | 
| PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse | from admission up to 6 hours post operation | 
| PFDI score - Pelvic Floor Disability Index | The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability. | from admission up to 6 hours post operation |