NCT04083313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

August 26, 2019

Last Update Submit

March 27, 2020

Conditions

Appendicitis AcuteLaparoscopic Surgery

Keywords

Laparoscopic appendectomyEndoloopEndostaplerEndoclip

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (19)

  • Value levels of leukocytes

    Before surgery

  • Duration of symptoms

    Before surgery

  • Height

    Before surgery

  • Weight

    Before surgery

  • C-reactive protein

    Before surgery

  • +14 more secondary outcomes

Study Arms (3)

Endoloop

ACTIVE COMPARATOR

Patients in which appendiceal stump was ligated using Endoloop

Device: Technique used for closing the appendiceal stump

Endostapler

ACTIVE COMPARATOR

Patients in which appendiceal stump was ligated using Endostapler

Device: Technique used for closing the appendiceal stump

Endoclip

ACTIVE COMPARATOR

Patients in which appendiceal stump was ligated using Endoclip

Device: Technique used for closing the appendiceal stump

Interventions

Technique used for closing the appendiceal stumpDEVICE

In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump

Also known as: Laparoscopic appendectomy
EndoclipEndoloopEndostapler

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

You may not qualify if:

  • Patients converted from laparoscopy to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (6)

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

    PMID: 23025946BACKGROUND

  • 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.

    PMID: 23386160BACKGROUND

  • 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.

    PMID: 15026904BACKGROUND

  • 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.

    PMID: 16862615BACKGROUND

  • 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.

    PMID: 8703146BACKGROUND

  • 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.

    PMID: 22269300BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Hepatobilliary surgery

Study Record Dates

First Submitted

August 26, 2019

First Posted

September 10, 2019

Study Start

January 1, 2019

Primary Completion

January 30, 2020

Study Completion

March 15, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)