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

Study Overview
=================
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.

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

Conditions
-----------------
Appendicitis Acute, Laparoscopic Surgery

Intervention / Treatment
-----------------
* Device: Technique used for closing the appendiceal stump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically and radiologically(Ultrasound) verified appendicitis Exclusion Criteria: Patients converted from laparoscopy to open surgery
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoloop<br>Patients in which appendiceal stump was ligated using Endoloop | Device: Technique used for closing the appendiceal stump<br>* In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump<br>* Other names: Laparoscopic appendectomy;|
| Active Comparator: Endostapler<br>Patients in which appendiceal stump was ligated using Endostapler | Device: Technique used for closing the appendiceal stump<br>* In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump<br>* Other names: Laparoscopic appendectomy;|
| Active Comparator: Endoclip<br>Patients in which appendiceal stump was ligated using Endoclip | Device: Technique used for closing the appendiceal stump<br>* In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump<br>* Other names: Laparoscopic appendectomy;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic appendectomy, Endoloop, Endostapler, Endoclip