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

NCT ID: NCT04083313

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis Acute Laparoscopic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoloop

Patients in which appendiceal stump was ligated using Endoloop

Group Type ACTIVE_COMPARATOR

Technique used for closing the appendiceal stump

Intervention Type DEVICE

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

Endostapler

Patients in which appendiceal stump was ligated using Endostapler

Group Type ACTIVE_COMPARATOR

Technique used for closing the appendiceal stump

Intervention Type DEVICE

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

Endoclip

Patients in which appendiceal stump was ligated using Endoclip

Group Type ACTIVE_COMPARATOR

Technique used for closing the appendiceal stump

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Technique used for closing the appendiceal stump

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Laparoscopic appendectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria

* Patients converted from laparoscopy to open surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mislav Rakić, MD

Head of the Department of Hepatobilliary surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UH Dubrava

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 23025946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23386160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15026904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16862615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8703146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22269300 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHDubrava1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.