Study on Laparoscopic Operation for Perforated Appendicitis

• Conditions: Perforated Appendicitis
• Interventions: Procedure: Laparoscopic appendectomy; Procedure: Open appendectomy

• Registration Number: NCT00677989
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.

Detailed Description

The role of laparoscopic appendectomy (LA) for perforated appendicitis is under investigation. According to the results of a previous retrospective study conducted in Far-Eastern Memorial Hospital comparing the clinical outcomes between perforated appendicitis patients treated by laparoscopic and open approach showed favored clinical outcomes for LA. Same as a few studies indicated that laparoscopic appendectomy is a safe and effective procedure for treating patients with perforated appendicitis in terms of hospital stay and wound complications. One the other hand, some authors still concern about the adverse effects of laparoscopy for ruptured appendicitis patients in terms of longer operation time and increased rates of postoperative abscess formation. We hypothesize that prolonged CO2 pneumoperitoneum will produce transient mesenteric ischemic and reperfusion injury when CO2 disinflation, and the free radicals and oxidative proteins provoked by reperfusion injury are responsible for the adverse reaction of LA. The objective of this prospective non-randomized controlled study is to examine the safety and efficacy of laparoscopic appendectomy and compare its outcome with that of the conventional approach for perforated appendicitis patients, with special emphasis on postoperative complication and oxidative stress resulted from pneumoperitoneum..

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Status Verified: 2009-01
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant.
• The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation.
• Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent.

Exclusion Criteria

• Age less than 12 years
• older than 80 years
• perforated appendicitis was not revealed by pathologic investigation
• diverticulitis being diagnosed during surgery
• pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation
• the patient declining to enroll in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LA	Laparoscopic appendectomy	LA group: patients with perforated appendicitis treated by laparoscopic operation intentionally
OA	Open appendectomy	OA group:patients with perforated appendicitis treated by open approach

Primary Outcome Measures

Name	Time	Method
paraoperative outcomes	till patients are discharged

Secondary Outcome Measures

Name	Time	Method
levels of paraoperative serum cytokines, free radicals, and oxidized proteins.	since preoperative preparation till 48 hours after operation

Trial Locations

Locations (1)

Surgical Department, Far-Eastern Memorial Hospital; 🇨🇳 Taipei, Taiwan