- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618666
Laparoscopic Versus Open Appendectomy
February 21, 2021 updated by: mena helmy, Assiut University
Laparoscopic Versus Open Appendectomy in the Management of Chronic Appendicitis
comparison between laparoscopic and open appendectomy in the management of chronic appendicitis
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: laparoscopic and open appendectomy
comparative study between laparoscopic and open appendectomy
|
laparoscopic and open surgery to remove an inflammed appendix in chronic appendicitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assesment of operative time
Time Frame: 1 hour
|
discover whether open or laparoscopic appendectomy takes longer time
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
September 18, 2020
First Submitted That Met QC Criteria
November 1, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 21, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lap appendectomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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