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Evaluation the Role of Laparoscopic Management of Perforated Appendicitis

Primary Purpose

Perforated Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic management of perforated appendicitis
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Appendicitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of acute perforated appendicitis
  • fit for laparoscopy and general anesthesia.
  • written informed consent.
  • short term outcome data and agree to provide contact information.

Exclusion Criteria:

  • high risk for general anesthesia.
  • Appendicular abscess and appendicular mass .
  • ongoing infections including chest infections .
  • Children and pregnant females .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Evaluation the role of Laparoscopic management of perforated a

    Arm Description

    Outcomes

    Primary Outcome Measures

    early recovery
    recovery within 2 days

    Secondary Outcome Measures

    wound cosmetic appearance
    no scare of incision post laporscopic mangement

    Full Information

    First Posted
    August 20, 2017
    Last Updated
    August 27, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03267082
    Brief Title
    Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
    Official Title
    Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2017 (Anticipated)
    Primary Completion Date
    March 15, 2019 (Anticipated)
    Study Completion Date
    March 15, 2019 (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
    A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.
    Detailed Description
    The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery. this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Evaluation the role of Laparoscopic management of perforated a
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Laparoscopic management of perforated appendicitis
    Intervention Description
    Insertion of Ports Exposure of the Appendix peritoneal toilet and aspiration of pus after abdominal exposure Isolation of Mesoappendicular Artery Clipping and Dividing of the Artery Application of 3 x Endoloops Division of the Appendix Retrieval of the Appendix in an Endobag
    Primary Outcome Measure Information:
    Title
    early recovery
    Description
    recovery within 2 days
    Time Frame
    2 day
    Secondary Outcome Measure Information:
    Title
    wound cosmetic appearance
    Description
    no scare of incision post laporscopic mangement
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of acute perforated appendicitis fit for laparoscopy and general anesthesia. written informed consent. short term outcome data and agree to provide contact information. Exclusion Criteria: high risk for general anesthesia. Appendicular abscess and appendicular mass . ongoing infections including chest infections . Children and pregnant females .

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    6221925
    Citation
    Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
    Results Reference
    result
    PubMed Identifier
    8624197
    Citation
    Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.
    Results Reference
    result

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    Evaluation the Role of Laparoscopic Management of Perforated Appendicitis

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