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

Not Applicable
Completed
Conditions
Laparoscopic Surgery
Appendicitis Acute
Interventions
Device: Technique used for closing the appendiceal stump
Registration Number
NCT04083313
Lead Sponsor
University Hospital Dubrava
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • Patients with clinically and radiologically(Ultrasound) verified appendicitis
Exclusion Criteria
  • Patients converted from laparoscopy to open surgery

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EndoclipTechnique used for closing the appendiceal stumpPatients in which appendiceal stump was ligated using Endoclip
EndoloopTechnique used for closing the appendiceal stumpPatients in which appendiceal stump was ligated using Endoloop
EndostaplerTechnique used for closing the appendiceal stumpPatients in which appendiceal stump was ligated using Endostapler
Primary Outcome Measures
NameTimeMethod
Operative and postoperative complicationsSeven postoperative days

Complications will be presented as a percentage of the all operated patients.

Secondary Outcome Measures
NameTimeMethod
HeightBefore surgery

Meters

WeightBefore surgery

Kilograms

Duration of symptomsBefore surgery

Duration of symptoms will be measured in hours.

Value levels of leukocytesBefore surgery

Whit blood cells count

NeutrophilesBefore surgery

Neutrophile count

C-reactive proteinBefore surgery

Milligrams/liter

Body mass indexBefore surgery

Kilograms/meter square

Body temperatureBefore surgery

Body temperature will be measured in degrees celsius.

Length of the operationsDuring operation

Length of the operations will be presented in minutes.

Closure of the appendiceal stump using EndoloopDuring operation

Percentage of the all operated patients in which this technique was used.

Closure of the appendiceal stump using EndostaplerDuring operation

Percentage of the all operated patients in which this technique was used.

Closure of the appendiceal stump using EndoclipDuring operation

Percentage of the all operated patients in which this technique was used.

Number of reoperated patientsSeven days

Presented in total numbers

Hospital staySeven days

Length of the hospital stay will be presented in days.

Histopathological findingsSeven days

Histopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.

Percentage of reoperated patientsSeven days

Presented in percentages

Trial Locations

Locations (1)

UH Dubrava

🇭🇷

Zagreb, Croatia

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