Clinical Trial: APPEndicitis and Laparoscopic Criteria; APPEL Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy
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 Summary:
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.
Sponsor: University Medical Center Groningen
Current Primary Outcome: Accuracy of appendix characterization by histology or clinically [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Readmission [ Time Frame: 3 months ]
- Re-operation [ Time Frame: 3 months ]
- Intra-abdominal abcess [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: University Medical Center Groningen
Dates:
Date Received: January 21, 2010
Date Started: December 2009
Date Completion:
Last Updated: November 16, 2011
Last Verified: November 2011
