Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

Acute Appendicitis Clinical Trial

— CAS  

Official title:

Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750032
• Other study ID #: FNO-CHIR-CAS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2020
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Mayir B, Ensari CÖ, Bilecik T, Aslaner A, Oruç 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time will be measured in minutes and analysed.	12 months
Primary	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	Costs of surgery	Costs of surgery will be analysed for all groups of study subjects.	12 months
Secondary	Costs of hospitalization	The overall costs of hospitalisation will be analysed for all groups of study subjects.	12 months
Secondary	Costs of treatment of complications	Costs of treatment of complications will be analysed for all groups of study subjects.	12 months