0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Primary Purpose
Vaginal Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VNOTES/VH
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Prolapse
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VNOTES ARM
Vaginal hysterectomy Arm
Arm Description
treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.
treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.
Outcomes
Primary Outcome Measures
surgery time
time of surgery
Secondary Outcome Measures
bleeding
bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
hospital days
how many days after surgery for hospitalization
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
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.
Full Information
NCT ID
NCT04078802
First Posted
September 2, 2019
Last Updated
September 5, 2019
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04078802
Brief Title
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Official Title
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VNOTES ARM
Arm Type
Experimental
Arm Description
treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.
Arm Title
Vaginal hysterectomy Arm
Arm Type
Experimental
Arm Description
treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.
Intervention Type
Procedure
Intervention Name(s)
VNOTES/VH
Intervention Description
same as above
Primary Outcome Measure Information:
Title
surgery time
Description
time of surgery
Time Frame
from admission up to 6 hours post operation
Secondary Outcome Measure Information:
Title
bleeding
Description
bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
Time Frame
from admission up to 6 hours post operation
Title
hospital days
Description
how many days after surgery for hospitalization
Time Frame
from admission up to 96 hours post operation
Title
PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Description
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
Time Frame
from admission up to 6 hours post operation
Title
PFDI score - Pelvic Floor Disability Index
Description
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.
Time Frame
from admission up to 6 hours post operation
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women suffer from vaginal prolapse
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Mor, mD
Phone
972546486414
Email
omermor23@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Mor, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
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