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

April 17, 2023 updated by: Ulas Aday

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Detailed explanation will be made later if necessary.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Diyarbakır, Turkey, 21280
        • Dicle University Medical of School, Department of Gastrointestinal Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients operated on for acute appendicitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is it safe to close the appendix stump with a single hem-o-lok clip?
Time Frame: one year
Complications of patients using single and double clips will be compared according to Clavien-Dindo scoring system.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of single and double hem-o-lok clips on cost in laparoscopic appendectomy
Time Frame: one week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulas Aday

Investigators

  • Principal Investigator: Abdullah Oğuz, MD, Dicle University Medical of School
  • Study Chair: Ulaş Aday, MD, Dicle University Medical of School
  • Study Director: Mehmet veysi Bahadır, MD, Dicle University Medical of School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 'KartalH'

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since there are no plans yet, planning will be done later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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