Non-operative Treatment of Acute Non-perforated Appendicitis
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|ClinicalTrials.gov Identifier: NCT04030741|
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : February 21, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
|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|
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.
Appendectomy as treatment for acute appendicitis
- Pain relief [ Time Frame: 24 hour ]Pain relief assessed by visual analogue scale (VAS) score < 3
- Afebrile [ Time Frame: 24 hours ]Temperature less than 98 Fahrenheit.
- Food Tolerance [ Time Frame: 24 hour ]Child starts oral intake and had no symptoms after food intake.
- 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
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
|Contact: M. Nadeem sajjad||0343 4633359||Mazhar20211@gmail.com|
|Contact: Fatima Naumeri||0321 firstname.lastname@example.org|
|King Edward Medical University||Recruiting|
|Lahore, Punjab, Pakistan|
|Contact: zaheer abbas 0300 9421562 email@example.com|
|Principal Investigator:||Paediatric surgery department||King Edward Medical University|