Initial non-operative treatment versus direct operative treatment for simple appendicitis in childre

Phase 1

• Conditions: Acute uncomplicated (simple) appendicitis; MedDRA version: 19.0Level: PTClassification code 10003011Term: AppendicitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003052-70-NL
• Lead Sponsor: Academic Medical Center of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-19
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible for inclusion are all children from 7 to 17 years old, inclusive, with a radiologically confirmed simple appendicitis. Definition of simple appendicitis is based upon predefined clinical, biochemical and radiological (ultrasound) criteria.
Clinical & biochemical criteria:
-Unwell but not generally ill
-Localized tenderness in the right iliac fossa region
-Normal/hyperactive bowel sounds
-No guarding or palpable mass
-Biochemical signs of infection (Elevated White Blood Cell count (WBC) and/or C-reactive protein (CRP)).
As recommended by the national guideline, all children with a clinical and/or biochemical suspicion should undergo ultrasound studies. Ultrasound criteria to confirm the diagnosis of acute simple appendicitis are:
-An incompressible, painful appendix with an outer diameter > 6 mm
-Secondary signs of inflammation such as surrounding fat infiltration, limited clear free fluid surrounding the appendix, hyperemia within the appendiceal wall.
-No fecolith, no signs of perforation, no signs of intra-abdominal abscess or phlegmone.
In case the ultrasound is inconclusive, additional imaging studies may be obtained. CT-scan is not recommended in the young children (due to its risk of radiation induced malignancy). MRI is recommended in those places with sufficient experience in the interpretation of the results. Only those in whom imaging studies confirm the diagnosis of simple appendicitis can be included. In case there is no certain diagnosis and a watchful waiting” strategy is chosen, the patient cannot be included.

Are the trial subjects under 18? yes
Number of subjects for this age range: 334
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

•Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system). [21,22]
Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:
Diffuse abdominal guarding (3 points)
CRP level more than 38 mg/L (2 points)
Signs on ultrasound indicative of complex appendicitis (2 points)
More than one day abdominal pain (2 points)
Temperature: more than 37.5 degree Celsius (1 point)
•Fecolith (ultrasound)
•Serious co-morbidity
•Recurrent appendicitis
•Suspicion of an underlying malignancy or inflammatory bowel disease
•Documented type 1 allergy to the antibiotics used.

Study & Design

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