APPEndicitis and Laparoscopic Criteria; APPEL Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Haveman, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01054417
First received: January 21, 2010
Last updated: November 16, 2011
Last verified: November 2011

January 21, 2010
November 16, 2011
December 2009
April 2011   (final data collection date for primary outcome measure)
Accuracy of appendix characterization by histology or clinically [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054417 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
APPEndicitis and Laparoscopic Criteria; APPEL Study
A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Slices of the appendix fixed for pathologic examnination will be retained (standard procedure).

Non-Probability Sample

All patients who will undergo a diagnostic laparoscopy for the clinical diagnosis appendicitis.

Appendicitis
Not Provided
Appendicitis
Patients with suspected appendicitis who are to be operated upon by diagnostic laparoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
July 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01054417
APPEL01
No
JW Haveman, University Medical Centre Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: JW Haveman, MD, PhD University Medical Center Groningen, the Netherlands
University Medical Centre Groningen
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP