Back to resultsUse of v Care in Abdominal Hysterectomy
Primary Purpose
Uterine Fibroid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
uterine manipulator (v care)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroid
Eligibility Criteria
Inclusion Criteria:
- benign causes for hysterectomy
Exclusion Criteria:
- malignant causes for hysterectomy
Sites / Locations
- Ain Shams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
v care group
control group
Arm Description
In this group we will use (v care) uterine manipulator during abdominal hysterectomy.
In this group we will do abdominal hysterectomy without v care.
Outcomes
Primary Outcome Measures
Vaginal length
Secondary Outcome Measures
Bladder injury
Full Information
NCT ID
NCT02371811
First Posted
February 17, 2015
Last Updated
July 30, 2017
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02371811
Brief Title
Use of v Care in Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
v care group
Arm Type
Experimental
Arm Description
In this group we will use (v care) uterine manipulator during abdominal hysterectomy.
Arm Title
control group
Arm Type
No Intervention
Arm Description
In this group we will do abdominal hysterectomy without v care.
Intervention Type
Device
Intervention Name(s)
uterine manipulator (v care)
Other Intervention Name(s)
v care
Primary Outcome Measure Information:
Title
Vaginal length
Time Frame
within 1 week postoperative
Secondary Outcome Measure Information:
Title
Bladder injury
Time Frame
within 1 week postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
benign causes for hysterectomy
Exclusion Criteria:
malignant causes for hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed elsafty, md
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Use of v Care in Abdominal Hysterectomy
We'll reach out to this number within 24 hrs