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Open Versus Laparoscopic Appendectomy

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
open appendectomy
laparoscopic appendectomy
Sponsored by
North Karelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Appendicitis focused on measuring acute appendicitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age over 15 years
  • suspected acute appendicitis
  • suitability for laparoscopy

Exclusion Criteria:

  • patients refusal to participate
  • lack of a laparoscopic surgeon

Sites / Locations

  • North Karelia Central Hospital, Clinic of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

open appendectomy

laparoscopic appendectomy

Arm Description

Outcomes

Primary Outcome Measures

Complication; wound problem or other primary complication

Secondary Outcome Measures

Full Information

First Posted
May 26, 2009
Last Updated
May 26, 2009
Sponsor
North Karelia Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00908804
Brief Title
Open Versus Laparoscopic Appendectomy
Official Title
Open Versus Laparoscopic Appendectomy in Suspected Acute Appendicitis - a Prospective Randomised Clinical Trial With With 10-Year Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
North Karelia Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
acute appendicitis

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
open appendectomy
Arm Type
Active Comparator
Arm Title
laparoscopic appendectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
open appendectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic appendectomy
Primary Outcome Measure Information:
Title
Complication; wound problem or other primary complication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
North Karelia Central Hospital, Clinic of Surgery
City
Joensuu
ZIP/Postal Code
80210
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20632312
Citation
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.
Results Reference
derived

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Open Versus Laparoscopic Appendectomy

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