Study on Laparoscopic Operation for Perforated Appendicitis

NCT ID: NCT00677989

Last Updated: 2009-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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..

Conditions

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Perforated Appendicitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LA

LA group: patients with perforated appendicitis treated by laparoscopic operation intentionally

Laparoscopic appendectomy

Intervention Type PROCEDURE

laparoscopic appendectomy:did appendectomy by laparoscopic manipulation

OA

OA group:patients with perforated appendicitis treated by open approach

Open appendectomy

Intervention Type PROCEDURE

open appendectomy: did appendectomy by laparotomy

Interventions

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Laparoscopic appendectomy

laparoscopic appendectomy:did appendectomy by laparoscopic manipulation

Intervention Type PROCEDURE

Open appendectomy

open appendectomy: did appendectomy by laparotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Traumatology Department,Far-Eastern Memorial Hospital, Taipei , Taiwan

Principal Investigators

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Heng-Fu Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Traumatology division, Surgical department, Far-Eastern Memorial Hospital

Locations

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Surgical Department, Far-Eastern Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Heng-Fu Lin, MD

Role: CONTACT

886-2-8966-7000 ext. 1612

References

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Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.

Reference Type BACKGROUND
PMID: 6221925 (View on PubMed)

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. doi: 10.1016/s0002-9610(99)00017-3.

Reference Type BACKGROUND
PMID: 10219865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9950122 (View on PubMed)

Golub R, Siddiqui F, Pohl D. Laparoscopic versus open appendectomy: a metaanalysis. J Am Coll Surg. 1998 May;186(5):545-53. doi: 10.1016/s1072-7515(98)00080-5.

Reference Type BACKGROUND
PMID: 9583695 (View on PubMed)

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. doi: 10.1007/s004230050135.

Reference Type BACKGROUND
PMID: 9776459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10526524 (View on PubMed)

Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.

Reference Type BACKGROUND
PMID: 8624197 (View on PubMed)

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. doi: 10.1016/s0002-9610(97)00286-9.

Reference Type BACKGROUND
PMID: 9560127 (View on PubMed)

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. doi: 10.1007/s00268-002-6457-7. Epub 2002 Sep 26.

Reference Type BACKGROUND
PMID: 12297916 (View on PubMed)

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. doi: 10.1016/j.gassur.2005.12.012.

Reference Type BACKGROUND
PMID: 16769550 (View on PubMed)

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. doi: 10.1097/00000658-199509000-00004.

Reference Type BACKGROUND
PMID: 7677456 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10871175 (View on PubMed)

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. doi: 10.1093/bja/69.4.341.

Reference Type BACKGROUND
PMID: 1419439 (View on PubMed)

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. doi: 10.1007/BF00187340.

Reference Type BACKGROUND
PMID: 7878501 (View on PubMed)

Other Identifiers

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FEMH No. 96044

Identifier Type: -

Identifier Source: org_study_id

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