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Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polymeric non absorbable clips
endoloops
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • . Able to give informed consent for inclusion in the study
  • Age of the patient : Any age

Exclusion Criteria:

  • • Intraoperative decision to convert to open appendicectomy

    • Primary open appendicectomy
    • Unable to give informed consent for participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    endoloop ligation

    non absorbable polymeric clips

    Arm Description

    securing appendicular base with endoloops

    securing appendicular base with non absorbable polymeric clips

    Outcomes

    Primary Outcome Measures

    Operative time
    Is there difference in the overall operating time between the two cohorts

    Secondary Outcome Measures

    Complications
    Is there a difference in the rate of intraoperative and postoperative complications
    Length of hospital stay (postoperative)
    Is there a significant difference in the length of postoperative stay between the two cohorts
    Readmission to hospital
    Is there a difference in the thirty day readmission rates between the two cohorts
    Time of Application
    Time of application of endoloop, polymeric clip measured from introducing of instruments to cutting the base of appendix

    Full Information

    First Posted
    September 17, 2019
    Last Updated
    September 18, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04094480
    Brief Title
    Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy
    Official Title
    A Comparison Between Non Absorbable Polymeric Clips and Endoloop Ligatures in Securing Appendicular Stump in Laparoscopic Appendicectomy at Assiut University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    March 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    a) Compare between Nonabsorbable Polymeric Clips and Endoloop ligatures regarding: technical difficulties. operation time. cost effectiveness. postoperative complications. inpatient stay.
    Detailed Description
    Laparoscopic appendectomy is gradually evolving as the 'gold standard' in the treatment of acute appendicitis, especially in the obese, elderly, and in cases where the diagnosis is uncertain . There are clear benefits with the laparoscopic approach in terms of decreased pain and faster recovery than the open approach . However, disadvantages like a higher incidence of intra-abdominal collection, longer operating time, and higher costs have been documented. These may be dependent on the technique of appendicular stump closure. Therefore, the technique for appendiceal stump closure is crucial in laparoscopic appendectomy. Laparoscopic appendectomy was first described by Semm in 1983 and is currently preferred approach for an appendectomy for many surgeons. Numerous methods of stump closure have been used, like intracorporeal suturing of the stump endoloop application, endostapler application LigaSure customized titanium clip application, and, more recently, using nonabsorbable plastic clips . Many of these techniques are either time consuming or expensive, or not available universally.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    endoloop ligation
    Arm Type
    Active Comparator
    Arm Description
    securing appendicular base with endoloops
    Arm Title
    non absorbable polymeric clips
    Arm Type
    Active Comparator
    Arm Description
    securing appendicular base with non absorbable polymeric clips
    Intervention Type
    Device
    Intervention Name(s)
    polymeric non absorbable clips
    Intervention Description
    a method to secure appendicular stump
    Intervention Type
    Other
    Intervention Name(s)
    endoloops
    Intervention Description
    a method to secure appendicular stump
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Is there difference in the overall operating time between the two cohorts
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    Complications
    Description
    Is there a difference in the rate of intraoperative and postoperative complications
    Time Frame
    30 days
    Title
    Length of hospital stay (postoperative)
    Description
    Is there a significant difference in the length of postoperative stay between the two cohorts
    Time Frame
    Up to 14 days
    Title
    Readmission to hospital
    Description
    Is there a difference in the thirty day readmission rates between the two cohorts
    Time Frame
    30 days
    Title
    Time of Application
    Description
    Time of application of endoloop, polymeric clip measured from introducing of instruments to cutting the base of appendix
    Time Frame
    120 min

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: . Able to give informed consent for inclusion in the study Age of the patient : Any age Exclusion Criteria: • Intraoperative decision to convert to open appendicectomy Primary open appendicectomy Unable to give informed consent for participation in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed ashraf, master
    Phone
    01060624371
    Email
    akhel93@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Morssy mohamed, professor
    Phone
    01006234545
    Email
    morssy.mohamed@med.au.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesham Ali, professor
    Organizational Affiliation
    Assiut university faculty of medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31446471
    Citation
    Kliuchanok K, Kessler W, Partecke I, Walschus U, Schulze T, Heidecke CD, Patrzyk M. A comparison of non-absorbable polymeric clips and staplers for laparoscopic appendiceal stump closure: analysis of 618 adult patients. Langenbecks Arch Surg. 2019 Sep;404(6):711-716. doi: 10.1007/s00423-019-01814-w. Epub 2019 Aug 24.
    Results Reference
    background
    PubMed Identifier
    29543058
    Citation
    Wilson M, Maniam P, Ibrahim A, Makaram N, Knight SR, Patil P. Polymeric clips are a quicker and cheaper alternative to endoscopic ligatures for securing the appendiceal stump during laparoscopic appendicectomy. Ann R Coll Surg Engl. 2018 Jul;100(6):454-458. doi: 10.1308/rcsann.2018.0036. Epub 2018 Mar 15.
    Results Reference
    background
    PubMed Identifier
    29190038
    Citation
    Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
    Results Reference
    background
    PubMed Identifier
    29098432
    Citation
    Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
    Results Reference
    background
    PubMed Identifier
    27996377
    Citation
    Pogorelic Z, Kostovski B, Jeroncic A, Susnjar T, Mrklic I, Jukic M, Juric I. A Comparison of Endoloop Ligatures and Nonabsorbable Polymeric Clips for the Closure of the Appendicular Stump During Laparoscopic Appendectomy in Children. J Laparoendosc Adv Surg Tech A. 2017 Jun;27(6):645-650. doi: 10.1089/lap.2016.0433. Epub 2016 Dec 20.
    Results Reference
    background

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    Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

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