Laparoscopic Versus Open Appendectomy

October 22, 2014 updated by: Varazdin General Hospital

Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis

Comparison of open and laparoscopic appendectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Varazdin, Croatia, 42000
        • Varazdin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis

Description

Inclusion Criteria:

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

Exclusion Criteria:Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
laparoscopic appendectomy
The laparoscopic appendectomy was performed with three trocars, placed in the periumbilical area, right midabdomen, and forceps.
Procedure: 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.
Other Names:
  • harmonic scalpel (UltraCision Ethicon ®)
  • fusion device (Covidien LigaSure™)
  • stapling device (Covidien Endo GIA™)
open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
Procedure: open appendectomy
The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost of hospitalization based on the final hospital bills
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia demands
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
The number of doses of analgesics, and time from surgery to the last dose of analgesics.
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Complications
Time Frame: during first 4 weeks after the surgery
No. of wound infection and intrabdominal abscesses.
during first 4 weeks after the surgery
Length of hospital stay
Time Frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
No. of days from surgery to discharge of hospital
from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Time until resumption of clear liquid and regular diet
Time Frame: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)
No. of days from surgery to the resumption of clear liquid and regular diet
from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varazdin General Hospital

Investigators

  • Principal Investigator: Ranko Stare, MD, PhD, Varazdin General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01091981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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