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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04083313
Enrollment
300
Registered
2019-09-10
Start date
2019-01-01
Completion date
2020-03-15
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis Acute, Laparoscopic Surgery

Keywords

Laparoscopic appendectomy, Endoloop, Endostapler, Endoclip

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.

Interventions

DEVICETechnique used for closing the appendiceal stump

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

Sponsors

University Hospital Dubrava
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion criteria

* Patients converted from laparoscopy to open surgery

Design outcomes

Primary

MeasureTime frameDescription
Operative and postoperative complicationsSeven postoperative daysNumber of all complications will be presented in total numbers.

Secondary

MeasureTime frameDescription
Histopathological findingsSeven daysHistopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.
Percentage of reoperated patientsSeven daysPresented in percentages
Number of reoperated patientsSeven daysPresented in total numbers
Value levels of leukocytesBefore surgeryWhit blood cells count
Duration of symptomsBefore surgeryDuration of symptoms will be measured in hours.
HeightBefore surgeryMeters
WeightBefore surgeryKilograms
Hospital staySeven daysLength of the hospital stay will be presented in days.
NeutrophilesBefore surgeryNeutrophile count
Body mass indexBefore surgeryKilograms/meter square
Body temperatureBefore surgeryBody temperature will be measured in degrees celsius.
Length of the operationsDuring operationLength of the operations will be presented in minutes.
Closure of the appendiceal stump using EndoloopDuring operationNumber of patients in which this technique was performed.
Closure of the appendiceal stump using EndostaplerDuring operationNumber of patients in which this technique was performed
Closure of the appendiceal stump using EndoclipDuring operationNumber of patients in which this technique was performed
C-reactive proteinBefore surgeryMilligrams/liter

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026