APPEndicitis and Laparoscopic Criteria; APPEL Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy|
- Accuracy of appendix characterization by histology or clinically [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Readmission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Re-operation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Intra-abdominal abcess [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Slices of the appendix fixed for pathologic examnination will be retained (standard procedure).
|Study Start Date:||December 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Patients with suspected appendicitis who are to be operated upon by diagnostic laparoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054417
|University Medical Center Groningen|
|Groningen, Netherlands, 9700RB|
|Principal Investigator:||JW Haveman, MD, PhD||University Medical Center Groningen, the Netherlands|