Clinical trial NCT00677989: Study on Laparoscopic Operation for Perforated Appendicitis
Official title: The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perforated Appendicitis
Keywords: perforated appendicitis
laparoscopic appendectomy
open appendectomy
cytokines
free radicals
oxidized proteins
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with perforated appendicitis treated at the Far-Eastern Memorial Hospital, Taipei,Taiwan

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..

Eligibility criteria: 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

Primary outcomes:
measure: paraoperative outcomes
timeFrame: till patients are discharged
Secondary outcomes:
measure: levels of paraoperative serum cytokines, free radicals, and oxidized proteins.
timeFrame: since preoperative preparation till 48 hours after operation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Surgical Department, Far-Eastern Memorial Hospital
Study officials:
affiliation: Traumatology division, Surgical department, Far-Eastern Memorial Hospital
name: Heng-Fu Lin, MD
role: PRINCIPAL_INVESTIGATOR
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