search
Back to results

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

Primary Purpose

Appendicitis Acute, Laparoscopic Surgery

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Technique used for closing the appendiceal stump
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Acute focused on measuring Laparoscopic appendectomy, Endoloop, Endostapler, Endoclip

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

  • Patients converted from laparoscopy to open surgery

Sites / Locations

  • UH Dubrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Endoloop

Endostapler

Endoclip

Arm Description

Patients in which appendiceal stump was ligated using Endoloop

Patients in which appendiceal stump was ligated using Endostapler

Patients in which appendiceal stump was ligated using Endoclip

Outcomes

Primary Outcome Measures

Operative and postoperative complications
Number of all complications will be presented in total numbers.
Operative and postoperative complications
Complications will be presented as a percentage of the all operated patients.

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2019
Last Updated
March 27, 2020
Sponsor
University Hospital Dubrava
search

1. Study Identification

Unique Protocol Identification Number
NCT04083313
Brief Title
Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy
Official Title
Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute, Laparoscopic Surgery
Keywords
Laparoscopic appendectomy, Endoloop, Endostapler, Endoclip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoloop
Arm Type
Active Comparator
Arm Description
Patients in which appendiceal stump was ligated using Endoloop
Arm Title
Endostapler
Arm Type
Active Comparator
Arm Description
Patients in which appendiceal stump was ligated using Endostapler
Arm Title
Endoclip
Arm Type
Active Comparator
Arm Description
Patients in which appendiceal stump was ligated using Endoclip
Intervention Type
Device
Intervention Name(s)
Technique used for closing the appendiceal stump
Other Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Primary Outcome Measure Information:
Title
Operative and postoperative complications
Description
Number of all complications will be presented in total numbers.
Time Frame
Seven postoperative days
Title
Operative and postoperative complications
Description
Complications will be presented as a percentage of the all operated patients.
Time Frame
Seven postoperative days
Secondary Outcome Measure Information:
Title
Value levels of leukocytes
Description
Whit blood cells count
Time Frame
Before surgery
Title
Duration of symptoms
Description
Duration of symptoms will be measured in hours.
Time Frame
Before surgery
Title
Height
Description
Meters
Time Frame
Before surgery
Title
Weight
Description
Kilograms
Time Frame
Before surgery
Title
C-reactive protein
Description
Milligrams/liter
Time Frame
Before surgery
Title
Neutrophiles
Description
Neutrophile count
Time Frame
Before surgery
Title
Body mass index
Description
Kilograms/meter square
Time Frame
Before surgery
Title
Body temperature
Description
Body temperature will be measured in degrees celsius.
Time Frame
Before surgery
Title
Length of the operations
Description
Length of the operations will be presented in minutes.
Time Frame
During operation
Title
Closure of the appendiceal stump using Endoloop
Description
Number of patients in which this technique was performed.
Time Frame
During operation
Title
Closure of the appendiceal stump using Endoloop
Description
Percentage of the all operated patients in which this technique was used.
Time Frame
During operation
Title
Closure of the appendiceal stump using Endostapler
Description
Number of patients in which this technique was performed
Time Frame
During operation
Title
Closure of the appendiceal stump using Endostapler
Description
Percentage of the all operated patients in which this technique was used.
Time Frame
During operation
Title
Closure of the appendiceal stump using Endoclip
Description
Number of patients in which this technique was performed
Time Frame
During operation
Title
Closure of the appendiceal stump using Endoclip
Description
Percentage of the all operated patients in which this technique was used.
Time Frame
During operation
Title
Number of reoperated patients
Description
Presented in total numbers
Time Frame
Seven days
Title
Hospital stay
Description
Length of the hospital stay will be presented in days.
Time Frame
Seven days
Title
Histopathological findings
Description
Histopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.
Time Frame
Seven days
Title
Percentage of reoperated patients
Description
Presented in percentages
Time Frame
Seven days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinically and radiologically(Ultrasound) verified appendicitis Exclusion Criteria: Patients converted from laparoscopy to open surgery
Facility Information:
Facility Name
UH Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23025946
Citation
Yaghoubian A, Kaji AH, Lee SL. Laparoscopic versus open appendectomy: outcomes analysis. Am Surg. 2012 Oct;78(10):1083-6.
Results Reference
background
PubMed Identifier
23386160
Citation
Rashid A, Nazir S, Kakroo SM, Chalkoo MA, Razvi SA, Wani AA. Laparoscopic interval appendectomy versus open interval appendectomy: a prospective randomized controlled trial. Surg Laparosc Endosc Percutan Tech. 2013 Feb;23(1):93-6. doi: 10.1097/SLE.0b013e318277df6a.
Results Reference
background
PubMed Identifier
15026904
Citation
Beldi G, Muggli K, Helbling C, Schlumpf R. Laparoscopic appendectomy using endoloops: a prospective, randomized clinical trial. Surg Endosc. 2004 May;18(5):749-50. doi: 10.1007/s00464-003-9156-z. Epub 2004 Mar 19.
Results Reference
background
PubMed Identifier
16862615
Citation
Beldi G, Vorburger SA, Bruegger LE, Kocher T, Inderbitzin D, Candinas D. Analysis of stapling versus endoloops in appendiceal stump closure. Br J Surg. 2006 Nov;93(11):1390-3. doi: 10.1002/bjs.5474.
Results Reference
background
PubMed Identifier
8703146
Citation
Wagner M, Aronsky D, Tschudi J, Metzger A, Klaiber C. Laparoscopic stapler appendectomy. A prospective study of 267 consecutive cases. Surg Endosc. 1996 Sep;10(9):895-9. doi: 10.1007/s004649900192.
Results Reference
background
PubMed Identifier
22269300
Citation
Safavi A, Langer M, Skarsgard ED. Endoloop versus endostapler closure of the appendiceal stump in pediatric laparoscopic appendectomy. Can J Surg. 2012 Feb;55(1):37-40. doi: 10.1503/cjs.023810.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs