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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT04078802

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Prolapse	Procedure: VNOTES/VH	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

surgery time [from admission up to 6 hours post operation]
time of surgery

Secondary Outcome Measures

bleeding [from admission up to 6 hours post operation]
bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Omer Mor, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omer MOR MD, Principle Investigator, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT04078802

Other Study ID Numbers:

RambamMD

First Posted:

Sep 6, 2019

Last Update Posted:

Sep 9, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Prolapse

Prolapse

Study Results

No Results Posted as of Sep 9, 2019