Non-operative Treatment of Acute Non-perforated Appendicitis

NCT04030741 | Completed Phase 2 DMC

• 1 other identifier: 201/RC/KEMU
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis

Keywords

Acute Appendicitis.; Pediatric Appendicitis Score (PAS).; Visual Analogue Scale (VAS) Score.

Outcome Measures

Primary Outcomes (3)

• Pain relief

  Pain relief assessed by visual analogue scale (VAS) score \< 3

  24 hour

• Afebrile

  Temperature less than 98 Fahrenheit.

  24 hours

• Food Tolerance

  Child starts oral intake and had no symptoms after food intake.

  24 hour

Secondary Outcomes (1)

• Recurrence of symptoms of acute appendicitis

  Within 3 months.

Study Arms (2)

Meronem and flagyl

ACTIVE COMPARATOR

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

Surgery (appendectomy)

ACTIVE COMPARATOR

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

Interventions

Meronem and flagyl DRUG

meronem and flagy

Also known as: Flagyl

Meronem and flagyl

Appendectomy PROCEDURE

Appendectomy as treatment for acute appendicitis

Surgery (appendectomy)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.

  PMID: 27437029 RESULT

Related Links

• Maggiore Hospital, AUSL, Bologna, Italy

MeSH Terms

Conditions

Appendicitis

Interventions

Meropenem; Metronidazole; Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Paediatric surgery department

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The individual who evaluates the outcome(s) of interest
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)