Study on Laparoscopic Operation for Perforated Appendicitis

Perforated Appendicitis Clinical Trial

Official title:

The Role of Oxidized Proteins and Free Radicals on Laparoscopic Operation for Perforated Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00677989
• Other study ID #: FEMH No. 96044
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2008
• Last updated: February 6, 2009
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2009
• Source: Far Eastern Memorial Hospital
• Contact: Heng-Fu Lin, MD
• Phone: 886-2-8966-7000
• Email: hengfu57[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis

Intervention

Procedure:
• Laparoscopic appendectomy
laparoscopic appendectomy:did appendectomy by laparoscopic manipulation
• Open appendectomy
open appendectomy: did appendectomy by laparotomy

Locations

Country	Name	City	State
Taiwan	Surgical Department, Far-Eastern Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (14)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	paraoperative outcomes		till patients are discharged	Yes
Secondary	levels of paraoperative serum cytokines, free radicals, and oxidized proteins.		since preoperative preparation till 48 hours after operation	No