Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083313
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mislav Rakić, MD, University Hospital Dubrava

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.

Condition or disease Intervention/treatment Phase
Appendicitis Acute Laparoscopic Surgery Device: Technique used for closing the appendiceal stump Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Endoloop
Patients in which appendiceal stump was ligated using Endoloop
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Name: Laparoscopic appendectomy

Active Comparator: Endostapler
Patients in which appendiceal stump was ligated using Endostapler
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Name: Laparoscopic appendectomy

Active Comparator: Endoclip
Patients in which appendiceal stump was ligated using Endoclip
Device: Technique used for closing the appendiceal stump
In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
Other Name: Laparoscopic appendectomy




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

  • Patients converted from laparoscopy to open surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083313


Locations
Layout table for location information
Croatia
UH Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava
Publications:
Layout table for additonal information
Responsible Party: Mislav Rakić, MD, Head of the Department of Hepatobilliary surgery, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT04083313    
Other Study ID Numbers: UHDubrava1
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mislav Rakić, MD, University Hospital Dubrava:
Laparoscopic appendectomy
Endoloop
Endostapler
Endoclip
Additional relevant MeSH terms:
Layout table for MeSH terms
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases