APPEndicitis and Laparoscopic Criteria; APPEL Study

Appendicitis Clinical Trial

— APPEL  

Official title:

A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054417
• Other study ID #: APPEL01
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: November 16, 2011
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of appendix characterization by histology or clinically		3 months	No
Secondary	Readmission		3 months	No
Secondary	Re-operation		3 months	No
Secondary	Intra-abdominal abcess		3 months	No