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

March 27, 2020 updated by: Mislav Rakić, MD, University Hospital Dubrava
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • UH Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

  • Patients converted from laparoscopy to open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Endoloop
Patients in which appendiceal stump was ligated using Endoloop
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Names:
  • Laparoscopic appendectomy
ACTIVE_COMPARATOR: Endostapler
Patients in which appendiceal stump was ligated using Endostapler
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Names:
  • Laparoscopic appendectomy
ACTIVE_COMPARATOR: Endoclip
Patients in which appendiceal stump was ligated using Endoclip
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Names:
  • Laparoscopic appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative and postoperative complications
Time Frame: Seven postoperative days
Number of all complications will be presented in total numbers.
Seven postoperative days
Operative and postoperative complications
Time Frame: Seven postoperative days
Complications will be presented as a percentage of the all operated patients.
Seven postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value levels of leukocytes
Time Frame: Before surgery
Whit blood cells count
Before surgery
Duration of symptoms
Time Frame: Before surgery
Duration of symptoms will be measured in hours.
Before surgery
Height
Time Frame: Before surgery
Meters
Before surgery
Weight
Time Frame: Before surgery
Kilograms
Before surgery
C-reactive protein
Time Frame: Before surgery
Milligrams/liter
Before surgery
Neutrophiles
Time Frame: Before surgery
Neutrophile count
Before surgery
Body mass index
Time Frame: Before surgery
Kilograms/meter square
Before surgery
Body temperature
Time Frame: Before surgery
Body temperature will be measured in degrees celsius.
Before surgery
Length of the operations
Time Frame: During operation
Length of the operations will be presented in minutes.
During operation
Closure of the appendiceal stump using Endoloop
Time Frame: During operation
Number of patients in which this technique was performed.
During operation
Closure of the appendiceal stump using Endoloop
Time Frame: During operation
Percentage of the all operated patients in which this technique was used.
During operation
Closure of the appendiceal stump using Endostapler
Time Frame: During operation
Number of patients in which this technique was performed
During operation
Closure of the appendiceal stump using Endostapler
Time Frame: During operation
Percentage of the all operated patients in which this technique was used.
During operation
Closure of the appendiceal stump using Endoclip
Time Frame: During operation
Number of patients in which this technique was performed
During operation
Closure of the appendiceal stump using Endoclip
Time Frame: During operation
Percentage of the all operated patients in which this technique was used.
During operation
Number of reoperated patients
Time Frame: Seven days
Presented in total numbers
Seven days
Hospital stay
Time Frame: Seven days
Length of the hospital stay will be presented in days.
Seven days
Histopathological findings
Time Frame: Seven days
Histopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.
Seven days
Percentage of reoperated patients
Time Frame: Seven days
Presented in percentages
Seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHDubrava1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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