AzTrials
AzTrials

Appendicitis AcuteNCT04083313

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

A study testing Technique used for closing the appendiceal stump in people with Appendicitis Acute and Laparoscopic Surgery, run by University Hospital Dubrava at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Appendicitis Acute, Laparoscopic Surgery
What is being tested?
Technique used for closing the appendiceal stump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteCroatia
Study dates
1 Jan 2019to 15 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Who cannot join

  • Patients converted from laparoscopy to open surgery

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • UH Dubrava

    Zagreb, 10000

Other trials in Croatia

About this study

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.

Read the 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.

Being tested
Technique used for closing the appendiceal stump
Keywords
Laparoscopic appendectomy, Endoloop, Endostapler, Endoclip
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technique used for closing the appendiceal stumpDevice

    Also called Laparoscopic appendectomy

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

Study groups in NCT04083313
Study groupRoleWhat they receive
EndoloopActive comparatorPatients in which appendiceal stump was ligated using Endoloop
Receives: Device: Technique used for closing the appendiceal stump
EndostaplerActive comparatorPatients in which appendiceal stump was ligated using Endostapler
Receives: Device: Technique used for closing the appendiceal stump
EndoclipActive comparatorPatients in which appendiceal stump was ligated using Endoclip
Receives: Device: Technique used for closing the appendiceal stump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative and postoperative complications

    Number of all complications will be presented in total numbers.

    Measured: Seven postoperative days

  2. Operative and postoperative complications

    Complications will be presented as a percentage of the all operated patients.

    Measured: Seven postoperative days

Secondary outcomes (19)

  1. Value levels of leukocytes

    Whit blood cells count

    Measured: Before surgery

  2. Duration of symptoms

    Duration of symptoms will be measured in hours.

    Measured: Before surgery

  3. Height

    Meters

    Measured: Before surgery

  4. Weight

    Kilograms

    Measured: Before surgery

  5. C-reactive protein

    Milligrams/liter

    Measured: Before surgery

  6. Neutrophiles

    Neutrophile count

    Measured: Before surgery

  7. Body mass index

    Kilograms/meter square

    Measured: Before surgery

  8. Body temperature

    Body temperature will be measured in degrees celsius.

    Measured: Before surgery

  9. Length of the operations

    Length of the operations will be presented in minutes.

    Measured: During operation

  10. Closure of the appendiceal stump using Endoloop

    Number of patients in which this technique was performed.

    Measured: During operation

  11. Closure of the appendiceal stump using Endoloop

    Percentage of the all operated patients in which this technique was used.

    Measured: During operation

  12. Closure of the appendiceal stump using Endostapler

    Number of patients in which this technique was performed

    Measured: During operation

  13. Closure of the appendiceal stump using Endostapler

    Percentage of the all operated patients in which this technique was used.

    Measured: During operation

  14. Closure of the appendiceal stump using Endoclip

    Number of patients in which this technique was performed

    Measured: During operation

  15. Closure of the appendiceal stump using Endoclip

    Percentage of the all operated patients in which this technique was used.

    Measured: During operation

  16. Number of reoperated patients

    Presented in total numbers

    Measured: Seven days

  17. Hospital stay

    Length of the hospital stay will be presented in days.

    Measured: Seven days

  18. Histopathological findings

    Histopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.

    Measured: Seven days

  19. Percentage of reoperated patients

    Presented in percentages

    Measured: Seven days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start1 Jan 2019
  3. Primary completion30 Jan 2020
  4. Study completion15 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083313
Sponsor's protocol ID
UHDubrava1
Status last verified
Mar 2020
First submitted
26 Aug 2019
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 23025946

  • 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.

    PubMed 23386160

  • 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.

    PubMed 15026904

  • 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.

    PubMed 16862615

  • 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.

    PubMed 8703146

  • 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.

    PubMed 22269300

Questions about this trial

What is this clinical trial studying?

A study testing Technique used for closing the appendiceal stump in people with Appendicitis Acute and Laparoscopic Surgery, run by University Hospital Dubrava at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative and postoperative complications (time frame: Seven postoperative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04083313, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in