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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083313
• Other study ID #: UHDubrava1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 15, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

• Patients converted from laparoscopy to open surgery

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute
• Laparoscopic Surgery

Intervention

Device:
• Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump

Locations

Country	Name	City	State
Croatia	UH Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

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. Epub 2004 Mar 19. — View 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. — View 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. — View 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. — View 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. — View Citation

Yaghoubian A, Kaji AH, Lee SL. Laparoscopic versus open appendectomy: outcomes analysis. Am Surg. 2012 Oct;78(10):1083-6. — View Citation

Outcome

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