Laparoscopic Versus Open Appendectomy

NCT ID: NCT01967745

Last Updated: 2014-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-09-30

Brief Summary

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Comparison of open and laparoscopic appendectomy

Detailed Description

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Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Conditions

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Acute Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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laparoscopic appendectomy

The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps.

laparoscopic appendectomy

Intervention Type PROCEDURE

The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.

open appendectomy

The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

open appendectomy

Intervention Type PROCEDURE

The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

Interventions

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laparoscopic appendectomy

The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.

Intervention Type PROCEDURE

open appendectomy

The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

Intervention Type PROCEDURE

Other Intervention Names

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harmonic scalpel (UltraCision Ethicon ®) fusion device (Covidien LigaSure™) stapling device (Covidien Endo GIA™)

Eligibility Criteria

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Inclusion Criteria

* patients older than 16 years with presumptive diagnosis of acute appendicitis

Exclusion Criteria

* cirrhosis
* ascites
* coagulation disorder
* diffuse peritonitis
* shock on admission
* large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varazdin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ranko Stare, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Varazdin General Hospital

Locations

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Varazdin General Hospital

Varaždin, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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01091981

Identifier Type: -

Identifier Source: org_study_id

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