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Non-operative Treatment of Acute Non-perforated Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030741
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Fatima Numeri, King Edward Medical University

Brief Summary:

Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is curative but it is an invasive procedure done under general anesthesia with different risks and complications during and after operation, leading to disturbance of child daily routines and activities. Reported rates of perioperative complications are from 5% - 10%, with serious complications occurring in 1% to 7% of patients.

Children presenting with acute (<2 days) right iliac fossa pain with pediatric appendicitis score >7, with none of the following on ultrasonography: abscess formation, or loss of the echogenic sub-mucosal layer of the appendix or presence of an appendicolith or periappendiceal fluid collection will be labeled as having appendicitis.

After diagnosis we divided the patients into two groups.patients in group A will be treated with antibiotics and appendectomy is done for group B patients.


Condition or disease Intervention/treatment Phase
Acute Appendicitis Drug: Meronem and flagyl Procedure: Appendectomy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After permission from the ethical review board (ERB), Children diagnosed with acute appendicitis and fulfilling the inclusion and exclusion criteria will be included in the study after taking informed consent from parents. All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Total sample size is 180 patiens and duration is 3 to 6 months.
Masking: None (Open Label)
Masking Description: The individual who evaluates the outcome(s) of interest
Primary Purpose: Treatment
Official Title: Non Operative Treatment With Antibiotics Vs Surgery for Acute Non Perforated Appendicitis in Children: A Randomized Controlled Trial.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Meronem and flagyl
Children in Non-operative treatment (group A) Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day) divided into 2 divided doses) and metronidazole (20 mg/kg/day divided into 3 doses for another 8 days.
Drug: Meronem and flagyl
meronem and flagy
Other Name: Flagyl

Active Comparator: Surgery (appendectomy)

Children in group B: appendectomy will b done and post operative single dose of antibiotics.

discharge after 24hour and Follow up after 1 week.

Procedure: Appendectomy
Appendectomy as treatment for acute appendicitis




Primary Outcome Measures :
  1. Pain relief [ Time Frame: 24 hour ]
    Pain relief assessed by visual analogue scale (VAS) score < 3

  2. Afebrile [ Time Frame: 24 hours ]
    Temperature less than 98 Fahrenheit.

  3. Food Tolerance [ Time Frame: 24 hour ]
    Child starts oral intake and had no symptoms after food intake.


Secondary Outcome Measures :
  1. Recurrence of symptoms of acute appendicitis [ Time Frame: Within 3 months. ]

    Child presented pain in right iliac fossa, nausea and loss appetite with PAS Score greater than 7.

    on examination: Tenderness and Rebound tenderness




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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having PAS score >7will be included in the study.

Exclusion Criteria:

  • Patient with suspicion of perforated appendicitis on the basis of generalized peritonitis and abscess formation on ultrasound.
  • Patients with an appendicular mass, diagnosed by clinical examination and ultrasonography.
  • Patient with previous non-operative treatment of acute appendicitis (recurrent appendicitis)
  • Patients with C-reactive proteins > 40 mg/L.
  • Patients with history of any previous abdominal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030741


Contacts
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Contact: M. Nadeem sajjad 0343 4633359 Mazhar20211@gmail.com
Contact: Fatima Naumeri 0321 4017065 fatimanaumeri@gmail.com

Locations
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Pakistan
King Edward Medical University Recruiting
Lahore, Punjab, Pakistan
Contact: zaheer abbas    0300 9421562    za662103@gmail.com   
Sponsors and Collaborators
King Edward Medical University
Investigators
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Principal Investigator: Paediatric surgery department King Edward Medical University
Additional Information:
Publications of Results:
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Responsible Party: Fatima Numeri, Assistant Professor, King Edward Medical University
ClinicalTrials.gov Identifier: NCT04030741    
Other Study ID Numbers: 201/RC/KEMU
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: First i have to publication of article then i want to make available for others.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fatima Numeri, King Edward Medical University:
Acute Appendicitis.
Pediatric Appendicitis Score (PAS).
Visual Analogue Scale (VAS) Score.
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents