Open Appendectomy Versus Laparoscopic Appendectomy
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Open appendectomy
Laparoscopic appendectomy with metal endoclips
Laparoscopic appendectomy with suture ligation
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life
Eligibility Criteria
Inclusion Criteria:
- The patients with a preoperative diagnosis of acute appendicitis
Exclusion Criteria:
- The patients who are not volunteered to join the study
- The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
- The patients who have additional pathologies accompanying acute appendicitis
Sites / Locations
- Dr. Sadi Konuk Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Open appendectomy
Metal endoclip
Intracorporeal suture ligation
Arm Description
The subjects will have open appendectomy procedure.
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
Outcomes
Primary Outcome Measures
Quality of life.
Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.
Secondary Outcome Measures
Cost-effectivity
The study will reveal which procedure for appendectomy is the most cost-effective one.
Full Information
NCT ID
NCT01260064
First Posted
December 13, 2010
Last Updated
May 25, 2011
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01260064
Brief Title
Open Appendectomy Versus Laparoscopic Appendectomy
Official Title
The Outcomes of Various Appendectomy Techniques in a High-volume Center.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
1. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.
Detailed Description
The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open appendectomy
Arm Type
Active Comparator
Arm Description
The subjects will have open appendectomy procedure.
Arm Title
Metal endoclip
Arm Type
Active Comparator
Arm Description
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
Arm Title
Intracorporeal suture ligation
Arm Type
Active Comparator
Arm Description
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
Intervention Type
Procedure
Intervention Name(s)
Open appendectomy
Other Intervention Name(s)
Open technique
Intervention Description
The subjects will have traditional open appendectomy procedure.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy with metal endoclips
Other Intervention Name(s)
Metal endoclip
Intervention Description
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy with suture ligation
Other Intervention Name(s)
Intracorporeal suture ligation
Intervention Description
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
Primary Outcome Measure Information:
Title
Quality of life.
Description
Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cost-effectivity
Description
The study will reveal which procedure for appendectomy is the most cost-effective one.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with a preoperative diagnosis of acute appendicitis
Exclusion Criteria:
The patients who are not volunteered to join the study
The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
The patients who have additional pathologies accompanying acute appendicitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Alis, MD
Organizational Affiliation
Dr. Sadi Konuk Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
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Open Appendectomy Versus Laparoscopic Appendectomy
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