Laparoscopic Versus Open Appendectomy

Study Overview
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Brief Summary
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Comparison of open and laparoscopic appendectomy

Detailed Description
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Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Official Title
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Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: laparoscopic appendectomy
* Procedure: open appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 16 years with presumptive diagnosis of acute appendicitis Exclusion Criteria:Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with: cirrhosis ascites coagulation disorder diffuse peritonitis shock on admission large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| laparoscopic appendectomy<br>The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps. | Procedure: laparoscopic appendectomy<br>* The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.<br>* Other names: stapling device (Covidien Endo GIA™);|
| open appendectomy<br>The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position). | Procedure: open appendectomy<br>* The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of hospitalization based on the final hospital bills |  | from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia demands | The number of doses of analgesics, and time from surgery to the last dose of analgesics. | from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days) | 
| Complications | No. of wound infection and intrabdominal abscesses. | during first 4 weeks after the surgery | 
| Length of hospital stay | No. of days from surgery to discharge of hospital | from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days) | 
| Time until resumption of clear liquid and regular diet | No. of days from surgery to the resumption of clear liquid and regular diet | from the beginning of the surgery to the resumption (an expected average 2 days after the surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open appendectomy, laparoscopic appendectomy, appendicitis