Back to resultsClosure of the Appendix Stump in Laparoscopic Appendectomy
Primary Purpose
Appendicitis, Surgery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clips
knotting
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis, Surgery focused on measuring Appendicitis; Laparoscopic Surgery; Cost Effectiveness
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of acute appendicitis
Exclusion Criteria:
- under 18 years of age
- other patology in addition to appendiceal pathology
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
clips
knotting
Arm Description
Closure of the appendix stump with hem-o-lok clips
Closure of the appendix stump with intracorporal knotting.
Outcomes
Primary Outcome Measures
cost effectiveness
cost of treatment from surgery to discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03930667
Brief Title
Closure of the Appendix Stump in Laparoscopic Appendectomy
Official Title
Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2015 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Orhan Üreyen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.
Detailed Description
Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Surgery
Keywords
Appendicitis; Laparoscopic Surgery; Cost Effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clips
Arm Type
Active Comparator
Arm Description
Closure of the appendix stump with hem-o-lok clips
Arm Title
knotting
Arm Type
Experimental
Arm Description
Closure of the appendix stump with intracorporal knotting.
Intervention Type
Procedure
Intervention Name(s)
clips
Intervention Type
Procedure
Intervention Name(s)
knotting
Primary Outcome Measure Information:
Title
cost effectiveness
Description
cost of treatment from surgery to discharge
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute appendicitis
Exclusion Criteria:
under 18 years of age
other patology in addition to appendiceal pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan Ureyen
Organizational Affiliation
Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
2015-2019
Learn more about this trial
Closure of the Appendix Stump in Laparoscopic Appendectomy
We'll reach out to this number within 24 hrs