Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy
- Conditions
- Acute Appendicitis
- Interventions
- Procedure: Hem-O-LockProcedure: Stapler appendectomyProcedure: Endoloop
- Registration Number
- NCT03750032
- Lead Sponsor
- University Hospital Ostrava
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- age ≥18 years
- acute appendicitis
- laparoscopic approach
- signed informed content
- necrosis or advanced inflammatory changes in the area of appendicular stump
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hem-O-Lock 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. Stapler appendectomy Stapler appendectomy A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler. Endoloop Endoloop A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
- Primary Outcome Measures
Name Time Method Operative time 12 months Operative time will be measured in minutes and analysed.
Incidence of intraoperative and postoperative complications 12 months The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.
- Secondary Outcome Measures
Name Time Method Costs of surgery 12 months Costs of surgery will be analysed for all groups of study subjects.
Costs of hospitalization 12 months The overall costs of hospitalisation will be analysed for all groups of study subjects.
Costs of treatment of complications 12 months Costs of treatment of complications will be analysed for all groups of study subjects.
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia