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Acute AppendicitisCASNCT03750032

Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

A study testing Stapler appendectomy, Endoloop and Hem-O-Lock in people with Acute Appendicitis, run by University Hospital Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Appendicitis
What is being tested?
Stapler appendectomy, Endoloop and Hem-O-Lock
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCzechia
Study dates
1 Jun 2018to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

Other trials in Czechia

About this study

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).

Read the 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.

Being tested
Stapler appendectomy, Endoloop, Hem-O-Lock
Keywords
acute appendicitis, laparoscopy, closure of appendicular stump, economical and medical outcomes
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stapler appendectomyProcedure or surgery

    The patients randomised for this intervention will undergo stapler appendectomy.

  • EndoloopProcedure or surgery

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

  • Hem-O-LockProcedure or surgery

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

Study groups in NCT03750032
Study groupRoleWhat they receive
Stapler appendectomyExperimentalA total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.
Receives: Procedure: Stapler appendectomy
EndoloopExperimentalA total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
Receives: Procedure: Endoloop
Hem-O-LockExperimentalA total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.
Receives: Procedure: Hem-O-Lock

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative time

    Operative time will be measured in minutes and analysed.

    Measured: 12 months

  2. Incidence of intraoperative and postoperative complications

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

    Measured: 12 months

Secondary outcomes (3)

  1. Costs of surgery

    Costs of surgery will be analysed for all groups of study subjects.

    Measured: 12 months

  2. Costs of hospitalization

    The overall costs of hospitalisation will be analysed for all groups of study subjects.

    Measured: 12 months

  3. Costs of treatment of complications

    Costs of treatment of complications will be analysed for all groups of study subjects.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start1 Jun 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients will be randomized into three groups of various appendicular stump closure.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03750032
Sponsor's protocol ID
FNO-CHIR-CAS
Acronym
CAS
Status last verified
Oct 2020
First submitted
2 Nov 2018
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators have not decided to make the individual participant data available to other researchers.

Publications

  • 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.

    PubMed 25097680

  • 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.

    PubMed 26963058

  • 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.

    PubMed 26668532

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

    PubMed 27121413

  • 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.

    PubMed 27627887

  • 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.

    PubMed 34059039

Questions about this trial

What is this clinical trial studying?

A study testing Stapler appendectomy, Endoloop and Hem-O-Lock in people with Acute Appendicitis, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative time (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750032, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.

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