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

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

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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