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NCT04387370 Clinical Trial

The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?

Acute Appendicitis Clinical Trial

Official title:
Comparison of Single and Double Hem-o-log Clips in Laparoscopic Appendectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04387370
Other study ID # 'KartalH'
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 18, 2023

Study information
Verified date April 2023
Source Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use, binding with endoloop and nonabsorbable clip are the most common methods. Although the stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the learning curve and surgical time are longer. Nonabsorbable clip application which has been used recently; Urethra was also used in appendectomy after its safety has been proven by large studies to close cystic ducts and vascular structures. Its advantages such as low cost, no need for a learning curve and shortening the surgical time have increased the frequency of use.In this prospective observational study; It will be aimed to investigate the effects of stump closure methods applied in laparoscopic appendectomy on short-term clinical results. In addition, the factors that determine the surgeon's stump closure method and cost results will be tried to be determined.

Description:

Detailed explanation will be made later if necessary.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 18, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria - diagnosis of acute appendicitis - Performing laparoscopic surgery - Patients with an ASA score of I-II-III Exclusion Criteria: - Appendectomies with the patient's refusal to participate in the study - Open surgery - Primary pathology without appendicitis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Dicle University Medical of School, Department of Gastrointestinal Surgery Diyarbakir

Sponsors (1)
Lead Sponsor Collaborator
Ulas Aday

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Is it safe to close the appendix stump with a single hem-o-lok clip? Complications of patients using single and double clips will be compared according to Clavien-Dindo scoring system. one year
Secondary The effect of single and double hem-o-lok clips on cost in laparoscopic appendectomy With the use of a single clip, surgery costs are expected to be less in dollars.Student's t-test will be used for cost analysis. one week
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