APPEndicitis and Laparoscopic Criteria; APPEL Study
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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 |
- 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).
| 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 |
All patients who will undergo a diagnostic laparoscopy for the clinical diagnosis appendicitis.
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| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9700RB | |
| 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 May 16, 2013