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'
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

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