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Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

Primary Purpose

Appendicitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic appendectomy using clipping.
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute complicated appendicitis. Perforated appendicitis (diagnosed intraoperatively) Patients who will undergo laparoscopic appendectomy. Exclusion Criteria: Patients with straight forward appendectomy. Patients who are not fit for laparoscopic appendectomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Laparoscopic clipping appendectomy

    Laparoscopic extracorporeal ligation appendectomy

    Arm Description

    This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.

    This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy.

    Outcomes

    Primary Outcome Measures

    Operative time
    Time of the total procedure.
    Postoperative complications
    All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection

    Secondary Outcome Measures

    Hospital stay
    Duration of hospital stay

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    January 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05637554
    Brief Title
    Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview
    Official Title
    Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    January 2024 (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
    No

    5. Study Description

    Brief Summary
    The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.
    Detailed Description
    Appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by McBurney in the 1890s. Since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work. There are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. In this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis. AS management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.

    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
    Model Description
    Participants will be divided randomly into two groups, in the first group the investigators will use clipping in securing the base of the appendix but in other groups investigators will use extracorporeal ligation.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic clipping appendectomy
    Arm Type
    Active Comparator
    Arm Description
    This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.
    Arm Title
    Laparoscopic extracorporeal ligation appendectomy
    Arm Type
    Active Comparator
    Arm Description
    This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic appendectomy using clipping.
    Intervention Description
    Laparoscopic appendectomy using clipping to secure the base of the appendix.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
    Intervention Description
    Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Time of the total procedure.
    Time Frame
    After procedure completion, an average of 1 hour.
    Title
    Postoperative complications
    Description
    All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection
    Time Frame
    Through study completion, an average of 1 year.
    Secondary Outcome Measure Information:
    Title
    Hospital stay
    Description
    Duration of hospital stay
    Time Frame
    Through the patient's hospital stay, an average of 1 week.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute complicated appendicitis. Perforated appendicitis (diagnosed intraoperatively) Patients who will undergo laparoscopic appendectomy. Exclusion Criteria: Patients with straight forward appendectomy. Patients who are not fit for laparoscopic appendectomy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor
    Phone
    +201005126585
    Email
    Mohamed.14223992@med.aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hisham Ali Riad Shaban, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Moustafa Mahmoud Ebrahem
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Moustafa Ali Sayed Mahmoud
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34604728
    Citation
    Bessoff KE, Choi J, Wolff CJ, Kashikar A, Carlos GM, Caddell L, Khan RI, Stave CD, Spain DA, Forrester JD. Evidence-based surgery for laparoscopic appendectomy: A stepwise systematic review. Surg Open Sci. 2021 Aug 26;6:29-39. doi: 10.1016/j.sopen.2021.08.001. eCollection 2021 Oct.
    Results Reference
    background
    PubMed Identifier
    34085112
    Citation
    Casas MA, Dreifuss NH, Schlottmann F. High-volume center analysis and systematic review of stump appendicitis: solving the pending issue. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1663-1672. doi: 10.1007/s00068-021-01707-y. Epub 2021 Jun 3.
    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

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    Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

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