Study on Laparoscopic Operation for Perforated Appendicitis

February 6, 2009 updated by: Far Eastern Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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..

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
paraoperative outcomes
Time Frame: till patients are discharged
till patients are discharged

Secondary Outcome Measures

Outcome Measure
Time Frame
levels of paraoperative serum cytokines, free radicals, and oxidized proteins.
Time Frame: since preoperative preparation till 48 hours after operation
since preoperative preparation till 48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Heng-Fu Lin, MD, Traumatology division, Surgical department, Far-Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

May 13, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (ESTIMATE)

May 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEMH No. 96044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perforated Appendicitis

Clinical Trials on Laparoscopic appendectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe