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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

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Operative and postoperative complications [ Time Frame: Seven postoperative days ]
    Number of all complications will be presented in total numbers.
  • Operative and postoperative complications [ Time Frame: Seven postoperative days ]
    Complications will be presented as a percentage of the all operated patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Value levels of leukocytes [ Time Frame: Before surgery ]
    Whit blood cells count
  • Duration of symptoms [ Time Frame: Before surgery ]
    Duration of symptoms will be measured in hours.
  • Height [ Time Frame: Before surgery ]
    Meters
  • Weight [ Time Frame: Before surgery ]
    Kilograms
  • C-reactive protein [ Time Frame: Before surgery ]
    Milligrams/liter
  • Neutrophiles [ Time Frame: Before surgery ]
    Neutrophile count
  • Body mass index [ Time Frame: Before surgery ]
    Kilograms/meter square
  • Body temperature [ Time Frame: Before surgery ]
    Body temperature will be measured in degrees celsius.
  • Length of the operations [ Time Frame: During operation ]
    Length of the operations will be presented in minutes.
  • Closure of the appendiceal stump using Endoloop [ Time Frame: During operation ]
    Number of patients in which this technique was performed.
  • Closure of the appendiceal stump using Endoloop [ Time Frame: During operation ]
    Percentage of the all operated patients in which this technique was used.
  • Closure of the appendiceal stump using Endostapler [ Time Frame: During operation ]
    Number of patients in which this technique was performed
  • Closure of the appendiceal stump using Endostapler [ Time Frame: During operation ]
    Percentage of the all operated patients in which this technique was used.
  • Closure of the appendiceal stump using Endoclip [ Time Frame: During operation ]
    Number of patients in which this technique was performed
  • Closure of the appendiceal stump using Endoclip [ Time Frame: During operation ]
    Percentage of the all operated patients in which this technique was used.
  • Number of reoperated patients [ Time Frame: Seven days ]
    Presented in total numbers
  • Hospital stay [ Time Frame: Seven days ]
    Length of the hospital stay will be presented in days.
  • Histopathological findings [ Time Frame: Seven days ]
    Histopathological findings will be graduated in 3 grades - phlegmonous,gangrenous and perforated.
  • Percentage of reoperated patients [ Time Frame: Seven days ]
    Presented in percentages
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy
Official Title  ICMJE Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Appendicitis Acute
  • Laparoscopic Surgery
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Endoloop
    Patients in which appendiceal stump was ligated using Endoloop
    Intervention: Device: Technique used for closing the appendiceal stump
  • Active Comparator: Endostapler
    Patients in which appendiceal stump was ligated using Endostapler
    Intervention: Device: Technique used for closing the appendiceal stump
  • Active Comparator: Endoclip
    Patients in which appendiceal stump was ligated using Endoclip
    Intervention: Device: Technique used for closing the appendiceal stump
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

Exclusion Criteria:

  • Patients converted from laparoscopy to open surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083313
Other Study ID Numbers  ICMJE UHDubrava1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mislav Rakić, MD, University Hospital Dubrava
Study Sponsor  ICMJE University Hospital Dubrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Dubrava
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP