Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVE

The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs.

Main research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ramon Gorter
• Collaborators: VU University Medical Center; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids; Gentamicins

Criteria

Inclusion Criteria:

• Age 7-17 years

• Radiologically confirmed simple appendicitis, defined as:

1. Clinical findings:

• Unwell, but not generally ill

• Localized tenderness in the right iliac fossa region

• Normal/hyperactive bowel sounds

• No guarding

• No mass palpable

2. Ultrasonography:

• Incompressible appendix with an outer diameter of ≥6 mm

• Hyperaemia within the appendiceal wall

• Without faecolith

• Infiltration of surrounding fat

• No signs of perforation

• No signs of intra-abdominal abscess/phlegmon

Exclusion Criteria:

• Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system).

• 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)

• C-Reactive Protein 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)

• Faecolith (ultrasound)

• Serious co-morbidity

• Recurrent appendicitis

• Suspicion of an underlying malignancy or inflammatory bowel disease

• Documented type 1 allergy to the antibiotics used.