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APPEndicitis and Laparoscopic Criteria; APPEL Study

NCT ID: NCT01054417

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appendicitis

Keywords

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Appendicitis Laparoscopy Appendectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Appendicitis

Patients with suspected appendicitis who are to be operated upon by diagnostic laparoscopy

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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JW Haveman

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JW Haveman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen, the Netherlands

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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APPEL01

Identifier Type: -

Identifier Source: org_study_id