Open Versus Laparoscopic Appendectomy | NCT00908804

Studies
Open Versus Laparoscopic Appendectomy

NCT00908804

Sponsor

North Karelia Central Hospital

Status

Completed

Last Update Posted

May 27, 2009Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Appendicitis

Interventions

open appendectomy
laparoscopic appendectomy

Countries

Finland

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

Status Module

Record Verification Date

May 2009

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 26, 2009

First Submission Date that Met QC Criteria

May 26, 2009

First Posted Date

May 27, 2009Estimated

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

May 26, 2009

Last Update Posted Date

May 27, 2009Estimated

Description Module

Brief Summary

The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open appendectomy	Active Comparator		Procedure: open appendectomy
laparoscopic appendectomy	Active Comparator		Procedure: laparoscopic appendectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
open appendectomy	Procedure		open appendectomy
laparoscopic appendectomy

Measure	Description	Time Frame
Complication; wound problem or other primary complication

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 15 years
suspected acute appendicitis
suitability for laparoscopy

Exclusion Criteria:

patients refusal to participate
lack of a laparoscopic surgeon

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Karelia Central Hospital, Clinic of Surgery		Joensuu		80210	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20632312	Derived	Kouhia ST, Heiskanen JT, Huttunen R, Ahtola HI, Kiviniemi VV, Hakala T. Long-term follow-up of a randomized clinical trial of open versus laparoscopic appendicectomy. Br J Surg. 2010 Sep;97(9):1395-400. doi: 10.1002/bjs.7114.

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases