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

U

University Hospital Ostrava

Status

Completed

Conditions

Acute Appendicitis

Treatments

Procedure: Endoloop
Procedure: Hem-O-Lock
Procedure: Stapler appendectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03750032
FNO-CHIR-CAS

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

Stapler appendectomy
Experimental group
Description:
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.
Treatment:
Procedure: Stapler appendectomy
Endoloop
Experimental group
Description:
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
Treatment:
Procedure: Endoloop
Hem-O-Lock
Experimental group
Description:
A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.
Treatment:
Procedure: Hem-O-Lock

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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