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.