Back to resultsLaparoscopic Versus Open Appendectomy
Primary Purpose
Acute Appendicitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Open appendectomy
Laparoscopic appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis
Eligibility Criteria
Inclusion Criteria:
- acute appendicitis
Exclusion Criteria:
- Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open appendectomy
Laparoscopic appendectomy
Arm Description
Subjects that underwent open surgery for appendicitis
Subjects that underwent laparoscopic surgery for appendicitis
Outcomes
Primary Outcome Measures
Hospital cost
Mean hospital cost (in Euro) for patients that underwent appendectomy
Wound infection
Number of patients with wound infection after appendectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867072
Brief Title
Laparoscopic Versus Open Appendectomy
Official Title
Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
5. Study Description
Brief Summary
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
593 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open appendectomy
Arm Type
Active Comparator
Arm Description
Subjects that underwent open surgery for appendicitis
Arm Title
Laparoscopic appendectomy
Arm Type
Active Comparator
Arm Description
Subjects that underwent laparoscopic surgery for appendicitis
Intervention Type
Procedure
Intervention Name(s)
Open appendectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Primary Outcome Measure Information:
Title
Hospital cost
Description
Mean hospital cost (in Euro) for patients that underwent appendectomy
Time Frame
3 days
Title
Wound infection
Description
Number of patients with wound infection after appendectomy
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute appendicitis
Exclusion Criteria:
Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
12. IPD Sharing Statement
Citations:
PubMed Identifier
27582784
Citation
Biondi A, Di Stefano C, Ferrara F, Bellia A, Vacante M, Piazza L. Laparoscopic versus open appendectomy: a retrospective cohort study assessing outcomes and cost-effectiveness. World J Emerg Surg. 2016 Aug 30;11(1):44. doi: 10.1186/s13017-016-0102-5. eCollection 2016.
Results Reference
derived
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Laparoscopic Versus Open Appendectomy
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