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
  Purpose

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.


Condition
Appendicitis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Accuracy of appendix characterization by histology or clinically [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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).


Enrollment: 142
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Appendicitis
Patients with suspected appendicitis who are to be operated upon by 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054417

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: JW Haveman, MD, PhD University Medical Center Groningen, the Netherlands
  More Information

No publications provided

Responsible Party: JW Haveman, Surgeon, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01054417     History of Changes
Other Study ID Numbers: APPEL01
Study First Received: January 21, 2010
Last Updated: November 16, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Appendicitis
Laparoscopy
Appendectomy

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014