Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaginal Prolapse
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 60
- Primary Endpoint
- surgery time
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Omer MOR MD
Principle Investigator
Rambam Health Care Campus
Eligibility Criteria
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 Frame: from admission up to 6 hours post operation
time of surgery
Secondary Outcomes
- PFDI score - Pelvic Floor Disability Index(from admission up to 6 hours post operation)
- hospital days(from admission up to 96 hours post operation)
- PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(from admission up to 6 hours post operation)
- bleeding(from admission up to 6 hours post operation)