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Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

Primary Purpose

Appendicitis Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open appendectomy
Conventional Lap appendectomy
Sponsored by
Abanoub Atif Fawzy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Acute focused on measuring Laparoscopic appendectomy

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patient age between 5-50 year old patient diagnosed as acute appendicitis Exclusion Criteria: pregnacy perforated appendix severe obese patient previous abdominal exploration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Open appendectomy

    Conventional lap appendectomy

    Arm Description

    Appendectomy will be done through Mcberney incision.

    Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).

    Outcomes

    Primary Outcome Measures

    Operative time
    Time needed for operation

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2022
    Last Updated
    July 14, 2023
    Sponsor
    Abanoub Atif Fawzy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05611489
    Brief Title
    Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
    Official Title
    Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Abanoub Atif Fawzy

    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
    laparoscopic versus open appendectomy prospective randomized control study.Both surgical methods are safe and well established in clinical practice but there has been a controversy about which surgical procedure is the most appropriate in this research we are going to demonstrate which operative procedure is more beneficial with less disadvantages.
    Detailed Description
    A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Using envelopes as an allocation concealment method. Each patient will receive two envelopes one contain paper which determine that patient will have open surgery and the other determine that patient will have lap surgery and neither patient nor experimenters know about them and patient shall choose one of them which will determine what surgery will patient undergo .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis Acute
    Keywords
    Laparoscopic appendectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    laparoscopic versus open appendectomy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Open appendectomy
    Arm Type
    Other
    Arm Description
    Appendectomy will be done through Mcberney incision.
    Arm Title
    Conventional lap appendectomy
    Arm Type
    Other
    Arm Description
    Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).
    Intervention Type
    Procedure
    Intervention Name(s)
    Open appendectomy
    Intervention Description
    performed With the patient in supine position.incision made lateral to McBurney's point.layers of the abdomen is exposed. If the cecum can be visualized, it can be mobilized and used to identify the appendix. Once the appendix is identified, the mesoappendix should be dissected and the appendiceal vessels divided between clamps. The appendiceal vessels are then ligated with silk sutures. A silk purse-string suture can then be placed around the appendiceal base.A 15-blade knife is then used to excise the appendix proximal to the right angle clamp.The appendiceal stump mucosa can be obliterated using electrocautery. Then good haemostasis and layered closure is done.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional Lap appendectomy
    Other Intervention Name(s)
    Multiport Lap appendectomy
    Intervention Description
    Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Time needed for operation
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient age between 5-50 year old patient diagnosed as acute appendicitis Exclusion Criteria: pregnacy perforated appendix severe obese patient previous abdominal exploration

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

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