NCT00677989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 9, 2009

Status Verified

January 1, 2009

Enrollment Period

2.6 years

First QC Date

May 13, 2008

Last Update Submit

February 6, 2009

Conditions

Perforated Appendicitis

Keywords

perforated appendicitislaparoscopic appendectomyopen appendectomycytokinesfree radicalsoxidized proteins

Outcome Measures

Primary Outcomes (1)

  • paraoperative outcomes

    till patients are discharged

Secondary Outcomes (1)

  • levels of paraoperative serum cytokines, free radicals, and oxidized proteins.

    since preoperative preparation till 48 hours after operation

Study Arms (2)

LA

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

Procedure: Laparoscopic appendectomy

OA

OA group:patients with perforated appendicitis treated by open approach

Procedure: Open appendectomy

Interventions

Laparoscopic appendectomyPROCEDURE

laparoscopic appendectomy:did appendectomy by laparoscopic manipulation

LA
Open appendectomyPROCEDURE

open appendectomy: did appendectomy by laparotomy

OA

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Department, Far-Eastern Memorial Hospital

Taipei, 220, Taiwan

RECRUITING

Related Publications (14)

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

    PMID: 6221925BACKGROUND

  • 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.

    PMID: 10219865BACKGROUND

  • 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.

    PMID: 9950122BACKGROUND

  • 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.

    PMID: 9583695BACKGROUND

  • 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.

    PMID: 9776459BACKGROUND

  • 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.

    PMID: 10526524BACKGROUND

  • 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.

    PMID: 8624197BACKGROUND

  • 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.

    PMID: 9560127BACKGROUND

  • 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.

    PMID: 12297916BACKGROUND

  • 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.

    PMID: 16769550BACKGROUND

  • 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.

    PMID: 7677456BACKGROUND

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

    PMID: 10871175BACKGROUND

  • 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.

    PMID: 1419439BACKGROUND

  • 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.

    PMID: 7878501BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Heng-Fu Lin, MD

    Traumatology division, Surgical department, Far-Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng-Fu Lin, MD

CONTACT

886-2-8966-7000hengfu57@yahoo.com.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 9, 2009

Record last verified: 2009-01

Locations

TW(1)