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

Rambam Health Care Campus60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vaginal Prolapse

Interventions

VNOTES/VHPROCEDURE

same as above

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

surgery time

time of surgery

Time frame: from admission up to 6 hours post operation

Secondary Outcomes

bleeding

bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.

Time frame: from admission up to 6 hours post operation

hospital days

how many days after surgery for hospitalization

Time frame: 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

Time frame: 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.

Time frame: from admission up to 6 hours post operation

Central Contacts

Omer Mor, mD

CONTACT

972546486414 omermor23@gmail.com

Data from ClinicalTrials.gov

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