Back to resultsVaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy
Primary Purpose
Surgical Wound Dehiscence
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Monopolar needle electrode
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Wound Dehiscence
Eligibility Criteria
Inclusion Criteria:
- All total laparoscopic hysterectomies performed by a single surgeon
- Both benign and malignant cases
- Completed laparoscopically
- Intracorporeal vaginal cuff suturing
Exclusion Criteria:
- Robotic hysterectomies
- Pelvic infection within 30 days before surgery
- Conversion to laparotomy
Sites / Locations
- Ankara University Medical Faculty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Coagulation mode
Cut mode
Arm Description
Colpotomy will be performed by monopolar needle electrode using coagulation mode
Colpotomy will be performed by monopolar needle electrode using cut mode
Outcomes
Primary Outcome Measures
Vaginal dehiscence
Vaginal dehiscence up to 3 months after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02879487
Brief Title
Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy
Official Title
Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Dehiscence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coagulation mode
Arm Type
Active Comparator
Arm Description
Colpotomy will be performed by monopolar needle electrode using coagulation mode
Arm Title
Cut mode
Arm Type
Active Comparator
Arm Description
Colpotomy will be performed by monopolar needle electrode using cut mode
Intervention Type
Device
Intervention Name(s)
Monopolar needle electrode
Intervention Description
Colpotomy during total laparoscopic hysterectomy
Primary Outcome Measure Information:
Title
Vaginal dehiscence
Description
Vaginal dehiscence up to 3 months after surgery
Time Frame
3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All total laparoscopic hysterectomies performed by a single surgeon
Both benign and malignant cases
Completed laparoscopically
Intracorporeal vaginal cuff suturing
Exclusion Criteria:
Robotic hysterectomies
Pelvic infection within 30 days before surgery
Conversion to laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre Şükür, MD
Organizational Affiliation
Ankara University
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy
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