NCT01054417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

January 21, 2010

Last Update Submit

November 16, 2011

Conditions

Appendicitis

Keywords

AppendicitisLaparoscopyAppendectomy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of appendix characterization by histology or clinically

    3 months

Secondary Outcomes (3)

  • Readmission

    3 months

  • Re-operation

    3 months

  • Intra-abdominal abcess

    3 months

Study Arms (1)

Appendicitis

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Informed consent
  • Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis
  • No age or gender limits

You may not qualify if:

  • Elective scheduled appendectomy
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Slices of the appendix fixed for pathologic examnination will be retained (standard procedure).

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • JW Haveman, MD, PhD

    University Medical Center Groningen, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

July 1, 2011

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

NL(1)