0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedSeptember 9, 2019
September 1, 2019
1 year
September 2, 2019
September 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
surgery time
time of surgery
from admission up to 6 hours post operation
Secondary Outcomes (4)
bleeding
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
PFDI score - Pelvic Floor Disability Index
from admission up to 6 hours post operation
Study Arms (2)
VNOTES ARM
EXPERIMENTALtreatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.
Vaginal hysterectomy Arm
EXPERIMENTALtreatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.
Interventions
Eligibility Criteria
You may qualify if:
- women with vaginal prolapse
- capable of having a surgery - assessed by an anesthesiologist
- women who approve of having the surgery
You may not qualify if:
- BMI over 40
- women who have recurrent PID (pelvic inflammatory disease)
- women with oncology records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omer Mor, MD
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
September 2, 2019
First Posted
September 6, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
September 9, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share