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

NCT04387370 | Completed

• 1 other identifier: 'KartalH'
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Appendicitis

Keywords

Laparoscopic appendectomy; Hem-o-lok clip; stump closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of single and double hem-o-lok clips on cost in laparoscopic appendectomy

  one week

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Patients over 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated on for acute appendicitis

You may qualify if:

• diagnosis of acute appendicitis
• Performing laparoscopic surgery
• Patients with an ASA score of I-II-III

You may not qualify if:

• Appendectomies with the patient's refusal to participate in the study
• Open surgery
• Primary pathology without appendicitis

Sponsors & Collaborators

• Ulas Aday: lead

Study Sites (1)

Dicle University Medical of School, Department of Gastrointestinal Surgery

Diyarbakır, 21280, Turkey (Türkiye)

Location

Related Publications (1)

• Aday U, Cetin E, Kafadar MT, Oguz A, Bahadir MV, Ulger BV, Gedik E, Girgin S, Yilmaz M. Single versus double Hem-o-lok clips to secure the apendiceal stump during laparoscopic appendectomy: a prospective randomized multicentric clinical trial. Langenbecks Arch Surg. 2024 Mar 8;409(1):89. doi: 10.1007/s00423-024-03281-4.

  PMID: 38457041 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Abdullah Oğuz, MD

  Dicle University Medical of School

  PRINCIPAL INVESTIGATOR

• Ulaş Aday, MD

  Dicle University Medical of School

  STUDY CHAIR

• Mehmet veysi Bahadır, MD

  Dicle University Medical of School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 13, 2020
• Study Start: September 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: April 18, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)