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APPEndicitis and Laparoscopic Criteria; APPEL Study (APPEL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054417
First Posted: January 22, 2010
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Haveman, University Medical Centre Groningen
  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 JW Haveman, University Medical Centre Groningen:

Primary Outcome Measures:
  • Accuracy of appendix characterization by histology or clinically [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Readmission [ Time Frame: 3 months ]
  • Re-operation [ Time Frame: 3 months ]
  • Intra-abdominal abcess [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054417


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

Responsible Party: JW Haveman, Surgeon, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01054417     History of Changes
Other Study ID Numbers: APPEL01
First Submitted: January 21, 2010
First Posted: January 22, 2010
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by JW Haveman, University Medical Centre Groningen:
Appendicitis
Laparoscopy
Appendectomy

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases