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Completed

NCT Number: NCT03750032

Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy

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).

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Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapler appendectomy

Procedure

The patients randomised for this intervention will undergo stapler appendectomy.

Endoloop

Procedure

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

Hem-O-Lock

Procedure

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

Primary outcomes

  1. Operative time

    Time frame: 12 months

    Operative time will be measured in minutes and analysed.

  2. Incidence of intraoperative and postoperative complications

    Time frame: 12 months

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

Secondary outcomes

  1. Costs of surgery

    Time frame: 12 months

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

  2. Costs of hospitalization

    Time frame: 12 months

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

  3. Costs of treatment of complications

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Acronym: CAS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2018
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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