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Study on Laparoscopic Operation for Perforated Appendicitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00677989
First received: May 13, 2008
Last updated: February 6, 2009
Last verified: January 2009

May 13, 2008
February 6, 2009
May 2008
December 2010   (final data collection date for primary outcome measure)
paraoperative outcomes [ Time Frame: till patients are discharged ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00677989 on ClinicalTrials.gov Archive Site
levels of paraoperative serum cytokines, free radicals, and oxidized proteins. [ Time Frame: since preoperative preparation till 48 hours after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study on Laparoscopic Operation for Perforated Appendicitis
The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis

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.

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..

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum

Probability Sample

Patients with perforated appendicitis treated at the Far-Eastern Memorial Hospital, Taipei,Taiwan

Perforated Appendicitis
  • Procedure: Laparoscopic appendectomy
    laparoscopic appendectomy:did appendectomy by laparoscopic manipulation
  • Procedure: Open appendectomy
    open appendectomy: did appendectomy by laparotomy
  • LA
    LA group: patients with perforated appendicitis treated by laparoscopic operation intentionally
    Intervention: Procedure: Laparoscopic appendectomy
  • OA
    OA group:patients with perforated appendicitis treated by open approach
    Intervention: Procedure: Open appendectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 80 Years
No
Contact: Heng-Fu Lin, MD 886-2-8966-7000 ext 1612 hengfu57@yahoo.com.tw
Taiwan
 
NCT00677989
FEMH No. 96044
No
Heng-Fu Lin, chief of the tramatology division, surgical department, Traumatology Department,Far-Eastern Memorial Hospital, Taipei , Taiwan
Far Eastern Memorial Hospital
Not Provided
Principal Investigator: Heng-Fu Lin, MD Traumatology division, Surgical department, Far-Eastern Memorial Hospital
Far Eastern Memorial Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP