Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: Stapler appendectomy
* Procedure: Endoloop
* Procedure: Hem-O-Lock


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into three groups of various appendicular stump closure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stapler appendectomy<br>A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler. | Procedure: Stapler appendectomy<br>* The patients randomised for this intervention will undergo stapler appendectomy.<br>|
| Experimental: Endoloop<br>A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop. | Procedure: Endoloop<br>* The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.<br>|
| Experimental: Hem-O-Lock<br>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<br>* The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs of surgery | Costs of surgery will be analysed for all groups of study subjects. | 12 months | 
| Costs of hospitalization | The overall costs of hospitalisation will be analysed for all groups of study subjects. | 12 months | 
| Costs of treatment of complications | Costs of treatment of complications will be analysed for all groups of study subjects. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute appendicitis, laparoscopy, closure of appendicular stump, economical and medical outcomes