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
About this trial
This is an interventional treatment trial for Chronic Inflammation of Appendix
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 .
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
NCT ID
NCT04618666
First Posted
September 18, 2020
Last Updated
February 21, 2021
Sponsor
Assiut University
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
Learn more about this trial
Laparoscopic Versus Open Appendectomy
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