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

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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Prolapse
• Intervention / Treatment: Procedure: VNOTES/VH

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omer Mor, mD; Phone Number: 972546486414; Email: omermor23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VNOTES ARM; treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.	Procedure: VNOTES/VH; same as above
Experimental: Vaginal hysterectomy Arm; treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.	Procedure: VNOTES/VH; same as above

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Omer Mor, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: RambamMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No