Clinical Trials Directory

Trials / Completed

CompletedNCT01054417

APPEndicitis and Laparoscopic Criteria; APPEL Study

A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy

Status
Completed
Phase
Study type
Observational
Enrollment
142 (actual)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

Detailed description

The UMCG hospital protocol of suspicion of appendicitis includes a diagnostic laparoscopy. The laparoscopic inspection of the appendix is carried out according to a specific protocol. In case of appendicitis the appendix is removed laparoscopically, a normal appendix is not removed. The primary outcome of the study is: appendicitis according to pathologic examination following appendectomy, or appendicitis according to clinical follow-up in case the appendix is not removed. The clinical diagnosis of appendicitis in the follow-up should be confirmed radiologic examination (ultrasound, CT-scan, MRI) or by a re-operation.

Conditions

Timeline

Start date
2009-12-01
Primary completion
2011-04-01
Completion
2011-07-01
First posted
2010-01-22
Last updated
2011-11-17

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01054417. Inclusion in this directory is not an endorsement.