Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy
NCT ID: NCT03750032
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-06-01
2019-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stapler appendectomy
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.
Stapler appendectomy
The patients randomised for this intervention will undergo stapler appendectomy.
Endoloop
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
Endoloop
The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.
Hem-O-Lock
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.
Hem-O-Lock
The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.
Interventions
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Stapler appendectomy
The patients randomised for this intervention will undergo stapler appendectomy.
Endoloop
The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.
Hem-O-Lock
The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.
Eligibility Criteria
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Inclusion Criteria
* acute appendicitis
* laparoscopic approach
* signed informed content
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Peter Ihnát, Ass.Prof.,MD,PhD,MBA
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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References
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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.
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.
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.
Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.
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.
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.
Other Identifiers
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FNO-CHIR-CAS
Identifier Type: -
Identifier Source: org_study_id
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