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Chronic Inflammation of AppendixNCT04618666

Laparoscopic Versus Open Appendectomy

A study testing laparoscopic and open surgery intervention in people with Chronic Inflammation of Appendix, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

comparison between laparoscopic and open appendectomy in the management of chronic appendicitis Read more about this study

Who is it for?
Ages 17 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Inflammation of Appendix
What is being tested?
laparoscopic and open surgery intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Dec 2021to Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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 .
Show all 9Show fewer
  • Patients who didn't give concent .
  • Children and pregnant women
  • Cases of complicated appendicitis .

Who cannot join

None listed.

About this study

Official title: Laparoscopic Versus Open Appendectomy in the Management of Chronic Appendicitis

comparison between laparoscopic and open appendectomy in the management of chronic appendicitis

Read the 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.

Being tested
laparoscopic and open surgery intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic and open surgery interventionProcedure or surgery

    laparoscopic and open surgery to remove an inflammed appendix in chronic appendicitis

Study groups in NCT04618666
Study groupRoleWhat they receive
laparoscopic and open appendectomyExperimentalcomparative study between laparoscopic and open appendectomy
Receives: Procedure: laparoscopic and open surgery intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assesment of operative time

    discover whether open or laparoscopic appendectomy takes longer time

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study startDec 2021 (estimated)
  3. Primary completionOct 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single group in which half of them will be operated open and the other half laparoscopic
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618666
Sponsor's protocol ID
Lap appendectomy
Status last verified
Nov 2020
First submitted
18 Sep 2020
Last updated
23 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic and open surgery intervention in people with Chronic Inflammation of Appendix, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assesment of operative time (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

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