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
  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

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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Responsible Party: Heng-Fu Lin, chief of the tramatology division, surgical department, Traumatology Department,Far-Eastern Memorial Hospital, Taipei , Taiwan
ClinicalTrials.gov Identifier: NCT00677989     History of Changes
Other Study ID Numbers: FEMH No. 96044
Study First Received: May 13, 2008
Last Updated: February 6, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
perforated appendicitis
laparoscopic appendectomy
open appendectomy
cytokines
free radicals
oxidized proteins

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Cecal Diseases
Digestive System Diseases
Disease Attributes
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Intraabdominal Infections
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014