Laparoscopic Versus Open Appendectomy

Completed

• Conditions: Acute Appendicitis
• Interventions: Procedure: open appendectomy; Procedure: laparoscopic appendectomy

• Registration Number: NCT01967745
• Lead Sponsor: Varazdin General Hospital

Brief Summary

Comparison of open and laparoscopic appendectomy

Detailed Description

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).

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-12
• Study Completion: 2013-09
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-23
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open appendectomy	open appendectomy	The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
laparoscopic appendectomy	laparoscopic appendectomy	The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Varazdin General Hospital; 🇭🇷 Varazdin, Croatia