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

Not Applicable

• Conditions: Vaginal Prolapse

• Registration Number: NCT04078802
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-09
• Study Start: 2019-10
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
surgery time	from admission up to 6 hours post operation	time of surgery

Secondary Outcome Measures

Name	Time	Method
PFDI score - Pelvic Floor Disability Index	from admission up to 6 hours post operation	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.
hospital days	from admission up to 96 hours post operation	how many days after surgery for hospitalization
PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire	from admission up to 6 hours post operation	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
bleeding	from admission up to 6 hours post operation	bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.