Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

NCT03750032 | Completed

• 1 other identifier: FNO-CHIR-CAS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic appendectomy (L-APPE) presents a golden standard in the treatment of acute appendicitis nowadays. However, there are ongoing controversies regarding the ideal technique of appendicular stump closure during L-APPE in the published literature. Several technical modifications of appendicular stump closure are available at the present - closure using endoloop, endostapler or Hem-o-lock clips. The aim of the proposed project (CAS study) is to compare medical and economic outcomes of patients undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop and Hem-o-lock clips).

Conditions

Acute Appendicitis

Keywords

acute appendicitis; laparoscopy; closure of appendicular stump; economical and medical outcomes

Outcome Measures

Primary Outcomes (2)

• Operative time

  Operative time will be measured in minutes and analysed.

  12 months

• Incidence of intraoperative and postoperative complications

  The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.

  12 months

Secondary Outcomes (3)

• Costs of surgery

  12 months

• Costs of hospitalization

  12 months

• Costs of treatment of complications

  12 months

Study Arms (3)

Stapler appendectomy

EXPERIMENTAL

A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.

Procedure: Stapler appendectomy

Endoloop

EXPERIMENTAL

A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.

Procedure: Endoloop

Hem-O-Lock

EXPERIMENTAL

A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.

Procedure: Hem-O-Lock

Interventions

Stapler appendectomy PROCEDURE

The patients randomised for this intervention will undergo stapler appendectomy.

Stapler appendectomy

Endoloop PROCEDURE

The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.

Endoloop

Hem-O-Lock PROCEDURE

The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.

Hem-O-Lock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• acute appendicitis
• laparoscopic approach
• signed informed content

You may not qualify if:

• \- necrosis or advanced inflammatory changes in the area of appendicular stump

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (6)

• Mayir B, Bilecik T, Ensari CO, Oruc MT. Laparoscopic appendectomy with hand-made loop. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):152-6. doi: 10.5114/wiitm.2014.41624. Epub 2014 Mar 24.

  PMID: 25097680 BACKGROUND

• Matyja M, Strzalka M, Rembiasz K. Laparosocopic Appendectomy, Cost-Effectiveness of Three Different Techniques Used to Close the Appendix Stump. Pol Przegl Chir. 2015 Dec;87(12):634-7. doi: 10.1515/pjs-2016-0015.

  PMID: 26963058 BACKGROUND

• Mayir B, Ensari CO, Bilecik T, Aslaner A, Oruc MT. Methods for closure of appendix stump during laparoscopic appendectomy procedure. Ulus Cerrahi Derg. 2015 Aug 18;31(4):229-31. doi: 10.5152/UCD.2015.2768. eCollection 2015.

  PMID: 26668532 BACKGROUND

• Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.

  PMID: 27121413 BACKGROUND

• Delibegovic S, Mehmedovic Z. Erratum to: The Influence of the Appendiceal Base Diameter on Appendix Stump Closure in Laparoscopic Appendectomy. World J Surg. 2016 Nov;40(11):2832. doi: 10.1007/s00268-016-3709-5. No abstract available.

  PMID: 27627887 BACKGROUND

• Ihnat P, Tesar M, Tulinsky L, Ihnat Rudinska L, Okantey O, Durdik S. A randomized clinical trial of technical modifications of appendix stump closure during laparoscopic appendectomy for uncomplicated acute appendicitis. BMC Surg. 2021 May 31;21(1):272. doi: 10.1186/s12893-021-01279-z.

  PMID: 34059039 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Ihnát, Ass.Prof.,MD,PhD,MBA

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized into three groups of various appendicular stump closure.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 21, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

CZ (1)