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Laparoscopic Versus Open Appendectomy

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ClinicalTrials.gov Identifier: NCT02867072
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Marco Vacante, University of Catania

Brief Summary:
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Procedure: Open appendectomy Procedure: Laparoscopic appendectomy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness
Study Start Date : January 2004
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Open appendectomy
Subjects that underwent open surgery for appendicitis
Procedure: Open appendectomy
Active Comparator: Laparoscopic appendectomy
Subjects that underwent laparoscopic surgery for appendicitis
Procedure: Laparoscopic appendectomy



Primary Outcome Measures :
  1. Hospital cost [ Time Frame: 3 days ]
    Mean hospital cost (in Euro) for patients that underwent appendectomy

  2. Wound infection [ Time Frame: 1 week ]
    Number of patients with wound infection after appendectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute appendicitis

Exclusion Criteria:

  • Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Vacante, MD, PhD, University of Catania
ClinicalTrials.gov Identifier: NCT02867072     History of Changes
Other Study ID Numbers: 01/2004
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases