Appendectomy in Children Performed by Residents in the Er... | NCT01657565

Studies
Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery

NCT01657565

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Aug 6, 2012Estimated

Enrollment

390Actual

Phase

Not provided

Conditions

Intraabdominal Abscess
Wound Infection

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Appendectomy in children	Registry Identifier	NMS OUH

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Aug 2, 2012

First Submission Date that Met QC Criteria

Aug 3, 2012

First Posted Date

Aug 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2012

Last Update Posted Date

Aug 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

390Actual

Measure	Description	Time Frame
Surgical complications		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age below 16 years. operated on suspicion of appendicitis

Exclusion Criteria:

appendectomy for causes other than suspicion of appendicitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

children 0-15 years of age having an appendectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense	Fyn	5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23340188	Derived	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.

Label	Type	Description	Intervention Names
open appendectomy
laparscopic appendectomy

ID	Term
D014946	Wound Infection
D045823	Ileus
D005334	Fever

ID	Term
D007239	Infections
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases