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Laparoscopic Versus Open Appendectomy

Primary Purpose

Chronic Inflammation of Appendix

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic and open surgery intervention
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammation of Appendix

Eligibility Criteria

17 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

clinical diagnosis of chronic appendicitis - - -Male or Female patients with chronic appendicitis

  • Patients who are fit for laparoscopy and general anaeshesia
  • Patients who provide a written informed concent
  • Patient who agree to provide short term outcome data and agree to provide

Exclusion Criteria - - -Patients with severe comorbid conditions with high risk for general anesthesia.

  • Patients suffering from an ongoing infections including chest infections .
  • Patients who didn't give concent .
  • Children and pregnant women
  • Cases of complicated appendicitis .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    laparoscopic and open appendectomy

    Arm Description

    comparative study between laparoscopic and open appendectomy

    Outcomes

    Primary Outcome Measures

    assesment of operative time
    discover whether open or laparoscopic appendectomy takes longer time

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2020
    Last Updated
    February 21, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04618666
    Brief Title
    Laparoscopic Versus Open Appendectomy
    Official Title
    Laparoscopic Versus Open Appendectomy in the Management of Chronic Appendicitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    March 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
    comparison between laparoscopic and open appendectomy in the management of chronic appendicitis
    Detailed Description
    The appendix is a blind-ended tube connected to the cecum, from which it develops in the embryo. The most common diseases of the appendix (in humans) are appendicitis and carcinoid tumors. Appendicitis is inflammation of the appendix. Symptoms commonly include right lower abdominal pain, nausea, vomiting, and decreased appetite. However, approximately 40% of people do not have these typical symptoms . Appendicitis is caused by a blockage of the hollow portion of the appendix. This is most commonly due to a calcified "stone" made of feces. Inflamed lymphoid tissue from a viral infection, parasites, gallstone, or tumors may also cause the blockage. This blockage leads to increased pressures in the appendix, decreased blood flow to the tissues of the appendix, and bacterial growth inside the appendix causing inflammation. The combination of inflammation, reduced blood flow to the appendix and distention of the appendix causes tissue injury and tissue death. If this process is left untreated, the appendix may burst, releasing bacteria into the abdominal cavity, leading to increased complications. The surgical procedure for the removal of the appendix is called an appendicectomy. Appendicectomy can be performed through open or laparoscopic surgery. The surgical procedure for the removal of the appendix is called an appendicectomy . Appendicectomy can be performed through open or laparoscopic surgery. When the surgeon uses the open approach, he makes an incision in the lower right section of the abdomen. Most incisions are less than 3 in (7.6 cm) in length. The surgeon then identifies all of the organs in the abdomen and examines them for other disease or abnormalities. The appendix is located and brought up into the wounds. The surgeon separates the appendix from all the surrounding tissue and its attachment to the cecum, and then removes it. The site where the appendix was previously attached, the cecum, is closed and returned to the abdomen The muscle layers and then the skin are sewn together . When the surgeon performs a laparoscopic appendectomy, four incisions, each about 1 in (2.5 cm) in length, are made. One incision is near the umbilicus, or navel, and one is between the umbilicus and the pubis. Two other incisions are smaller and are on the right side of the lower abdomen. The surgeon then passes a camera and special instruments through these incisions. With the aid of this equipment, the surgeon visually examines the abdominal organs and identifies the appendix. The appendix is then freed from all of its attachments and removed. The place where the appendix was formerly attached, the cecum, is stitched. The appendix is removed through one of the incisions. The instruments are removed and then all of the incisions are closed . The primary objective of this study was to compare the laparoscopic approach and the conventional technique in the treatment of chronic Appendicitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Inflammation of Appendix

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    single group in which half of them will be operated open and the other half laparoscopic
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic and open appendectomy
    Arm Type
    Experimental
    Arm Description
    comparative study between laparoscopic and open appendectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic and open surgery intervention
    Intervention Description
    laparoscopic and open surgery to remove an inflammed appendix in chronic appendicitis
    Primary Outcome Measure Information:
    Title
    assesment of operative time
    Description
    discover whether open or laparoscopic appendectomy takes longer time
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of chronic appendicitis - - -Male or Female patients with chronic appendicitis Patients who are fit for laparoscopy and general anaeshesia Patients who provide a written informed concent Patient who agree to provide short term outcome data and agree to provide Exclusion Criteria - - -Patients with severe comorbid conditions with high risk for general anesthesia. Patients suffering from an ongoing infections including chest infections . Patients who didn't give concent . Children and pregnant women Cases of complicated appendicitis .

    12. IPD Sharing Statement

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    Laparoscopic Versus Open Appendectomy

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