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Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy (CAS)

Primary Purpose

Acute Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Stapler appendectomy
Endoloop
Hem-O-Lock
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis focused on measuring acute appendicitis, laparoscopy, closure of appendicular stump, economical and medical outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stapler appendectomy

Endoloop

Hem-O-Lock

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Operative time
Operative time will be measured in minutes and analysed.
Incidence of intraoperative and postoperative complications
The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.

Secondary Outcome Measures

Costs of surgery
Costs of surgery will be analysed for all groups of study subjects.
Costs of hospitalization
The overall costs of hospitalisation will be analysed for all groups of study subjects.
Costs of treatment of complications
Costs of treatment of complications will be analysed for all groups of study subjects.

Full Information

First Posted
November 2, 2018
Last Updated
October 5, 2020
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03750032
Brief Title
Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy
Acronym
CAS
Official Title
Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Acute appendicitis presents one of the most common surgical illnesses which affect approximately 7% of the western population. In the Czech Republic, 11664 patients were hospitalized and operated for the diagnosis of acute appendicitis (K35-K38) during 2016. It might seem that the procedure of appendectomy will be guided by a clear algorithm for its frequency, but it is not so. Because of acute appendicitis, appendectomy may be performed via laparotomy or laparoscopy (minimally invasive surgery). During laparoscopic appendectomy (L-APPE), there are no clear recommendations regarding trocar placement, methods of dividing appendicular mesenteriolum, methods of appendicular stump closure or appendicular stump sinking. The proposed clinical study is focused on the issue of the appendicular base interruption during L-APPE. At the present, there are several technical modifications of appendicular stump closure - by means of endoloop (the suture loop from absorbable fiber), endostapler or using Hem-o-lock clips. The performed literature search revealed that evidence-based medicine data regarding the optimal way of appendicular stump closure are insufficient. That is why the investigators have decided to conduct a prospective randomized single-center clinical study aimed to compare different technical modifications of appendicular stump closure during L-APPE. Within a study period, all patients undergoing L-APPE at the University Hospital Ostrava will be randomized to one of the technical modifications of appendicular stump closure. The aim of the 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). The operative time, intraoperative and postoperative complications will be the primary outcome measures of the study, economic outcomes will be the secondary outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
Keywords
acute appendicitis, laparoscopy, closure of appendicular stump, economical and medical outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into three groups of various appendicular stump closure.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stapler appendectomy
Arm Type
Experimental
Arm Description
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.
Arm Title
Endoloop
Arm Type
Experimental
Arm Description
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
Arm Title
Hem-O-Lock
Arm Type
Experimental
Arm Description
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.
Intervention Type
Procedure
Intervention Name(s)
Stapler appendectomy
Intervention Description
The patients randomised for this intervention will undergo stapler appendectomy.
Intervention Type
Procedure
Intervention Name(s)
Endoloop
Intervention Description
The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.
Intervention Type
Procedure
Intervention Name(s)
Hem-O-Lock
Intervention Description
The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.
Primary Outcome Measure Information:
Title
Operative time
Description
Operative time will be measured in minutes and analysed.
Time Frame
12 months
Title
Incidence of intraoperative and postoperative complications
Description
The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Costs of surgery
Description
Costs of surgery will be analysed for all groups of study subjects.
Time Frame
12 months
Title
Costs of hospitalization
Description
The overall costs of hospitalisation will be analysed for all groups of study subjects.
Time Frame
12 months
Title
Costs of treatment of complications
Description
Costs of treatment of complications will be analysed for all groups of study subjects.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥18 years acute appendicitis laparoscopic approach signed informed content Exclusion Criteria: - necrosis or advanced inflammatory changes in the area of appendicular stump
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ihnát, Ass.Prof.,MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators have not decided to make the individual participant data available to other researchers.
Citations:
PubMed Identifier
25097680
Citation
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.
Results Reference
background
PubMed Identifier
26963058
Citation
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.
Results Reference
background
PubMed Identifier
26668532
Citation
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.
Results Reference
background
PubMed Identifier
27121413
Citation
Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.
Results Reference
background
PubMed Identifier
27627887
Citation
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.
Results Reference
background
PubMed Identifier
34059039
Citation
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.
Results Reference
derived

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Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

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