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

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078802
• Other study ID #: RambamMD
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: November 2020

Study information

• Verified date: September 2019
• Source: Rambam Health Care Campus
• Contact: Omer Mor, mD
• Phone: 972546486414
• Email: omermor23[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Procedure:
• VNOTES/VH
same as above

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgery time	time of surgery	from admission up to 6 hours post operation
Secondary	bleeding	bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.	from admission up to 6 hours post operation
Secondary	hospital days	how many days after surgery for hospitalization	from admission up to 96 hours post operation
Secondary	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
Secondary	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