APPEndicitis and Laparoscopic Criteria; APPEL Study

Completed

• Conditions: Appendicitis

• Registration Number: NCT01054417
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Informed consent
• Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis
• No age or gender limits

Exclusion Criteria

• Elective scheduled appendectomy
• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of appendix characterization by histology or clinically	3 months

Secondary Outcome Measures

Name	Time	Method
Readmission	3 months
Re-operation	3 months
Intra-abdominal abcess	3 months

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands