ClinicalTrials.Veeva

Menu

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

R

Rambam Health Care Campus

Status

Unknown

Conditions

Vaginal Prolapse

Treatments

Procedure: VNOTES/VH

Study type

Interventional

Funder types

Other

Identifiers

NCT04078802
RambamMD

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

25 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

VNOTES ARM
Experimental group
Description:
treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.
Treatment:
Procedure: VNOTES/VH
Vaginal hysterectomy Arm
Experimental group
Description:
treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.
Treatment:
Procedure: VNOTES/VH

Trial contacts and locations

0

Loading...

Central trial contact

Omer Mor, mD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems