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NCT Number: NCT04083313

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

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.

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Key information

Conditions

Appendicitis Acute Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Laparoscopic Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Dubrava

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion criteria

  • Patients converted from laparoscopy to open surgery

Treatment and study plan

Technique used for closing the appendiceal stump

Device

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

Other names: Laparoscopic appendectomy

Primary outcomes

  1. Operative and postoperative complications

    Time frame: Seven postoperative days

    Number of all complications will be presented in total numbers.

  2. Operative and postoperative complications

    Time frame: Seven postoperative days

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

Secondary outcomes

  1. Value levels of leukocytes

    Time frame: Before surgery

    Whit blood cells count

  2. Duration of symptoms

    Time frame: Before surgery

    Duration of symptoms will be measured in hours.

  3. Height

    Time frame: Before surgery

    Meters

  4. Weight

    Time frame: Before surgery

    Kilograms

  5. C-reactive protein

    Time frame: Before surgery

    Milligrams/liter

  6. Neutrophiles

    Time frame: Before surgery

    Neutrophile count

  7. Body mass index

    Time frame: Before surgery

    Kilograms/meter square

  8. Body temperature

    Time frame: Before surgery

    Body temperature will be measured in degrees celsius.

  9. Length of the operations

    Time frame: During operation

    Length of the operations will be presented in minutes.

  10. Closure of the appendiceal stump using Endoloop

    Time frame: During operation

    Number of patients in which this technique was performed.

  11. Closure of the appendiceal stump using Endoloop

    Time frame: During operation

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

  12. Closure of the appendiceal stump using Endostapler

    Time frame: During operation

    Number of patients in which this technique was performed

  13. Closure of the appendiceal stump using Endostapler

    Time frame: During operation

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

  14. Closure of the appendiceal stump using Endoclip

    Time frame: During operation

    Number of patients in which this technique was performed

  15. Closure of the appendiceal stump using Endoclip

    Time frame: During operation

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

  16. Number of reoperated patients

    Time frame: Seven days

    Presented in total numbers

  17. Hospital stay

    Time frame: Seven days

    Length of the hospital stay will be presented in days.

  18. Histopathological findings

    Time frame: Seven days

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

  19. Percentage of reoperated patients

    Time frame: Seven days

    Presented in percentages

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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