Study on Laparoscopic Operation for Perforated Appendicitis - Full Text View

Sponsored by:	Far Eastern Memorial Hospital
Information provided by:	Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00677989

Purpose

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.

Condition	Intervention
Perforated Appendicitis	Procedure: Laparoscopic appendectomy Procedure: Open appendectomy

MedlinePlus related topics: Appendicitis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:

paraoperative outcomes [ Time Frame: till patients are discharged ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
LA LA group: patients with perforated appendicitis treated by laparoscopic operation intentionally	Procedure: Laparoscopic appendectomy laparoscopic appendectomy:did appendectomy by laparoscopic manipulation
OA OA group:patients with perforated appendicitis treated by open approach	Procedure: Open appendectomy open appendectomy: did appendectomy by laparotomy

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

Ages Eligible for Study:	12 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677989

Contacts

Contact: Heng-Fu Lin, MD

886-2-8966-7000 ext 1612

hengfu57@yahoo.com.tw

Locations

Taiwan
Surgical Department, Far-Eastern Memorial Hospital	Recruiting
Taipei, Taiwan, 220

Sponsors and Collaborators

Far Eastern Memorial Hospital

Investigators

Principal Investigator:

Heng-Fu Lin, MD

Traumatology division, Surgical department, Far-Eastern Memorial Hospital

More Information

Publications:

Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64.

Chung RS, Rowland DY, Li P, Diaz J. A meta-analysis of randomized controlled trials of laparoscopic versus conventional appendectomy. Am J Surg. 1999 Mar;177(3):250-6.

Garbutt JM, Soper NJ, Shannon WD, Botero A, Littenberg B. Meta-analysis of randomized controlled trials comparing laparoscopic and open appendectomy. Surg Laparosc Endosc. 1999 Jan;9(1):17-26.

Golub R, Siddiqui F, Pohl D. Laparoscopic versus open appendectomy: a metaanalysis. J Am Coll Surg. 1998 May;186(5):545-53.

Sauerland S, Lefering R, Holthausen U, Neugebauer EA. Laparoscopic vs conventional appendectomy--a meta-analysis of randomised controlled trials. Langenbecks Arch Surg. 1998 Aug;383(3-4):289-95.

Temple LK, Litwin DE, McLeod RS. A meta-analysis of laparoscopic versus open appendectomy in patients suspected of having acute appendicitis. Can J Surg. 1999 Oct;42(5):377-83.

Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3.

Klingler A, Henle KP, Beller S, Rechner J, Zerz A, Wetscher GJ, Szinicz G. Laparoscopic appendectomy does not change the incidence of postoperative infectious complications. Am J Surg. 1998 Mar;175(3):232-5.

So JB, Chiong EC, Chiong E, Cheah WK, Lomanto D, Goh P, Kum CK. Laparoscopic appendectomy for perforated appendicitis. World J Surg. 2002 Dec;26(12):1485-8. Epub 2002 Sep 26.

Lin HF, Wu JM, Tseng LM, Chen KH, Huang SH, Lai IR. Laparoscopic versus open appendectomy for perforated appendicitis. J Gastrointest Surg. 2006 Jun;10(6):906-10.

Martin LC, Puente I, Sosa JL, Bassin A, Breslaw R, McKenney MG, Ginzburg E, Sleeman D. Open versus laparoscopic appendectomy. A prospective randomized comparison. Ann Surg. 1995 Sep;222(3):256-61; discussion 261-2.

Yao CC, Lin CS, Yang CC. Laparoscopic appendectomy for ruptured appendicitis. Surg Laparosc Endosc Percutan Tech. 1999 Aug;9(4):271-3.

Joris J, Cigarini I, Legrand M, Jacquet N, De Groote D, Franchimont P, Lamy M. Metabolic and respiratory changes after cholecystectomy performed via laparotomy or laparoscopy. Br J Anaesth. 1992 Oct;69(4):341-5.

Cho JM, LaPorta AJ, Clark JR, Schofield MJ, Hammond SL, Mallory PL 2nd. Response of serum cytokines in patients undergoing laparoscopic cholecystectomy. Surg Endosc. 1994 Dec;8(12):1380-3; discussion 1383-4.

Responsible Party:	Traumatology Department,Far-Eastern Memorial Hospital, Taipei , Taiwan ( Heng-Fu Lin, chief of the tramatology division, surgical department )
Study ID Numbers:	FEMH No. 96044
Study First Received:	May 13, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00677989
Health Authority:	Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:

perforated appendicitis
laparoscopic appendectomy
open appendectomy

cytokines
free radicals
oxidized proteins

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Appendicitis
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Cecal Diseases

ClinicalTrials.gov processed this record on January 16, 2009