NCT01657565

Brief Summary

Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital. Material and methods: All children (age\<16 years) treated surgically with appendectomy in our department between January 2006 and January 2011 were retrospectively identified. Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were considered as non-satisfactory outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

January 1, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

5 years

First QC Date

August 2, 2012

Last Update Submit

August 3, 2012

Conditions

Intraabdominal AbscessWound Infection

Keywords

LOSIleusFeverreoperation

Outcome Measures

Primary Outcomes (1)

  • Surgical complications

    30 days

Study Arms (2)

open appendectomy

laparscopic appendectomy

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children 0-15 years of age having an appendectomy

You may qualify if:

  • age below 16 years. operated on suspicion of appendicitis

You may not qualify if:

  • appendectomy for causes other than suspicion of appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (1)

  • Stilling NM, Fristrup C, Gabers T, Qvist N, Rasmussen L. Acceptable outcome after laparoscopic appendectomy in children. Dan Med J. 2013 Jan;60(1):A4564.

    PMID: 23340188DERIVED

MeSH Terms

Conditions

Wound InfectionIleusFever

Condition Hierarchy (Ancestors)

InfectionsIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

January 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

DK(1)