Study of efficinency of drug treatment for non-complicated acute appendicitis in 7 to 18 years old children.

Phase 1

• Conditions: Acute non-complicated appendicitis in patients aged 7 to 18; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-001729-38-LV
• Lead Sponsor: Arnis Engelis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-06
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age: 7-18 years
Dg. Primary acute non-complicated appendicitis
ALVORADO score = 7
Pain in right lower quadrant of abdomen
Blood tests:
C-reactive protein = 10 mg/L
*If performed:
*Il-6 = 39,2 pg/mL
*Ultrasound - acute appendicitis signs

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Positive pregnancy test
Diffuse peritonitis
Previous abdominal surgery
Use of antibiotic drugs in previous 7 days
Inflammatory bowel disease
Immunosuppresive condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To perform a complex clinical and economical study in children with acute appendicitis, provide new criteria for early diagnosis of acute non-complicated appendicitis and its conservative treatment, as well as evaluate cost-efficiency.;Secondary Objective: Not applicable;Primary end point(s): Full recovery.<br>Initial treatment failure - appendectomy performed.<br>1-year recurrance free.;Timepoint(s) of evaluation of this end point: Day 1-3: in-patient treatment.<br>Day 4-10: out-patient treatment.<br>Follow-up on month 1 and month 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in inflammation marker levels during hosital stay.<br>Abdominal pain 1 year after treatment.;Timepoint(s) of evaluation of this end point: Days 1-3 - daily<br>Follow-up on month 12.