Clinical trial NCT04083313: 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
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Laparoscopic Surgery
Keywords: Laparoscopic appendectomy
Endoloop
Endostapler
Endoclip
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

* Patients converted from laparoscopy to open surgery

Primary outcomes:
measure: Operative and postoperative complications
timeFrame: Seven postoperative days
measure: Operative and postoperative complications
timeFrame: Seven postoperative days
Secondary outcomes:
measure: Value levels of leukocytes
timeFrame: Before surgery
measure: Duration of symptoms
timeFrame: Before surgery
measure: Height
timeFrame: Before surgery
measure: Weight
timeFrame: Before surgery
measure: C-reactive protein
timeFrame: Before surgery
measure: Neutrophiles
timeFrame: Before surgery
measure: Body mass index
timeFrame: Before surgery
measure: Body temperature
timeFrame: Before surgery
measure: Length of the operations
timeFrame: During operation
measure: Closure of the appendiceal stump using Endoloop
timeFrame: During operation
measure: Closure of the appendiceal stump using Endoloop
timeFrame: During operation
measure: Closure of the appendiceal stump using Endostapler
timeFrame: During operation
measure: Closure of the appendiceal stump using Endostapler
timeFrame: During operation
measure: Closure of the appendiceal stump using Endoclip
timeFrame: During operation
measure: Closure of the appendiceal stump using Endoclip
timeFrame: During operation
measure: Number of reoperated patients
timeFrame: Seven days
measure: Hospital stay
timeFrame: Seven days
measure: Histopathological findings
timeFrame: Seven days
measure: Percentage of reoperated patients
timeFrame: Seven days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UH Dubrava
Study officials:
References:
citation: Yaghoubian A, Kaji AH, Lee SL. Laparoscopic versus open appendectomy: outcomes analysis. Am Surg. 2012 Oct;78(10):1083-6.
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.
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.
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.
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.
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.