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Laparoscopic Versus Open Appendectomy

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ClinicalTrials.gov Identifier: NCT01967745
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Varazdin General Hospital

Brief Summary:
Comparison of open and laparoscopic appendectomy

Condition or disease Intervention/treatment
Acute Appendicitis Procedure: laparoscopic appendectomy Procedure: open appendectomy

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).

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

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).




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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.

  2. Complications [ Time Frame: during first 4 weeks after the surgery ]
    No. of wound infection and intrabdominal abscesses.

  3. 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

  4. 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



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967745


Locations
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Croatia
Varazdin General Hospital
Varazdin, Croatia, 42000
Sponsors and Collaborators
Varazdin General Hospital
Investigators
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Principal Investigator: Ranko Stare, MD, PhD Varazdin General Hospital

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Responsible Party: Varazdin General Hospital
ClinicalTrials.gov Identifier: NCT01967745     History of Changes
Other Study ID Numbers: 01091981
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Varazdin General Hospital:
open appendectomy
laparoscopic appendectomy
appendicitis

Additional relevant MeSH terms:
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Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes