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Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy

U

University Hospital Dubrava

Status

Completed

Conditions

Laparoscopic Surgery
Appendicitis Acute

Treatments

Device: Technique used for closing the appendiceal stump

Study type

Interventional

Funder types

Other

Identifiers

NCT04083313
UHDubrava1

Details and patient eligibility

About

In this randomized control trial the patients with acute appendicitis will be divided in three groups according to the management of the appendiceal stump(Endostapler, Endoloop or Endoclip). Pre-, peri- and postoperative data will be analysed.

Full description

Acute appendicitis is the most common indication for intraabdominal emergency surgery, and appendectomy is one of the most commonly performed procedures in abdominal surgery. Today laparoscopic appendectomy (LA) has the status of a ''Gold Standard'' treatment, and it is accepted as the treatment of choice for acute appendicitis.There are several ways of closing the appendiceal stump.An inadequate closure of the appendiceal stump can lead to morbidity of operated patients. The aim of this study is to assess the efficiency of different closure techniques by focusing on the intraoperative and postoperative complications.The patients will be divided into three groups based on the technique used for appendiceal stump closure, whether it is Endoloop, Endostapler or Endoclip. In the patients included in the study the investigators will analyse demographic data, peroperative laboratory values, clinical data and treatment outcomes. Also, the histopathological findings of the specimens and perioperative and postoperative complications will be analysed.

Enrollment

300 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion criteria

  • Patients converted from laparoscopy to open surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 3 patient groups

Endoloop
Active Comparator group
Description:
Patients in which appendiceal stump was ligated using Endoloop
Treatment:
Device: Technique used for closing the appendiceal stump
Endostapler
Active Comparator group
Description:
Patients in which appendiceal stump was ligated using Endostapler
Treatment:
Device: Technique used for closing the appendiceal stump
Endoclip
Active Comparator group
Description:
Patients in which appendiceal stump was ligated using Endoclip
Treatment:
Device: Technique used for closing the appendiceal stump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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