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Closure of the Appendix Stump in Laparoscopic Appendectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930667
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Orhan Üreyen, Bozyaka Training and Research Hospital

Brief Summary:
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.

Condition or disease Intervention/treatment Phase
Appendicitis, Surgery Procedure: clips Procedure: knotting Not Applicable

Detailed Description:
Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study
Actual Study Start Date : March 25, 2015
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: clips
Closure of the appendix stump with hem-o-lok clips
Procedure: clips
Experimental: knotting
Closure of the appendix stump with intracorporal knotting.
Procedure: knotting



Primary Outcome Measures :
  1. cost effectiveness [ Time Frame: 4 years ]
    cost of treatment from surgery to discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of acute appendicitis

Exclusion Criteria:

  • under 18 years of age
  • other patology in addition to appendiceal pathology

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): NCT03930667


Sponsors and Collaborators
Orhan Üreyen
Investigators
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Principal Investigator: Orhan Ureyen Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir
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Responsible Party: Orhan Üreyen, Clinical expert in General Surgery,Principal Investigator, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03930667    
Other Study ID Numbers: 24.03.2015-no:3
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: 2015-2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orhan Üreyen, Bozyaka Training and Research Hospital:
Appendicitis; Laparoscopic Surgery; Cost Effectiveness
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases