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

NCT02848820 | Unknown Phase 4 DMC

• 1 other identifier: APAC2016
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 15

Brief 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?

Conditions

Appendicitis

Keywords

Appendicitis; Appendectomy; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing complications

  One year follow up

Secondary Outcomes (16)

• Number of days absent from school, social or sport events

  7 days, 1,6,12 months

• Number of days absent from work

  7 days, 1,6,12 months

• Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain.

  7 days, 1,6,12 months

• Total length of hospital stay during the follow-up period for strategy related treatment or complications

  7 days, 1,6,12 months

• Total days of analgesics medication use.

  one month

Study Arms (2)

Augmentin + Gentamicin

EXPERIMENTAL

Initial non-operative treatment strategy reserving an appendectomy for those not responding or with recurrent disease. It consist of: Clinical observation for 48 hours with administration of Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily for 48 hours. If after 48 hours the patient fulfils the predefined discharge criteria, the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days and discharge. An appendectomy is reserved for those patients with clinical deterioration, non-improvement after 72 hours or recurrent appendicitis. Pain medication according to national protocol.

Drug: Augmentin + Gentamicin

Operative treatment strategy

ACTIVE COMPARATOR

Clinical observation and semi-urgent appendectomy. Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics. Discharge if the patient fulfils the predefined discharge criteria. Pain medication according to national protocol.

Procedure: Appendectomy

Interventions

Augmentin + Gentamicin DRUG

Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours

Also known as: Amoxicillin/clavulanic acid (Augmentin) + Gentamicin

Augmentin + Gentamicin

Appendectomy PROCEDURE

Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics

Operative treatment strategy

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-17 years
• Radiologically confirmed simple appendicitis, defined as:
• Clinical findings:
• Unwell, but not generally ill
• Localized tenderness in the right iliac fossa region
• Normal/hyperactive bowel sounds
• No guarding
• No mass palpable
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramon Gorter: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (15)

Medical Center Alkmaar

Alkmaar, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Amstelland

Amstelveen, Netherlands

Location

AMC

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

VU University medical center

Amsterdam, Netherlands

Location

Gelre Hospital

Apeldoorn, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Red Cross Hospital

Beverwijk, Netherlands

Location

Albert Schweitzer

Dordrecht, Netherlands

Location

Maxima medical center

Eindhoven, Netherlands

Location

Zuyderland

Heerlen, Netherlands

Location

Antonius Hospital

Nieuwegein, Netherlands

Location

Franciscus, Gasthuis en Vlietland

Rotterdam, Netherlands

Location

Haga ziekenhuis

The Hague, Netherlands

Location

Related Publications (1)

• Knaapen M, van der Lee JH, Bakx R, The SL, van Heurn EWE, Heij HA, Gorter RR; APAC collaborative study group. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). BMJ Open. 2017 Nov 15;7(11):e018145. doi: 10.1136/bmjopen-2017-018145.

  PMID: 29146647 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Amoxicillin-Potassium Clavulanate Combination; Gentamicins; Amoxicillin; Clavulanic Acid; Appendectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Aminoglycosides; Glycosides; Carbohydrates; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ernst van Heurn, MD PhD

  Pediatric Surgical Center of Amsterdam (VUmc & AMC)

  STUDY CHAIR

• Ramon Gorter, MD

  Pediatric Surgical Center of Amsterdam (VUmc & AMC)

  STUDY DIRECTOR

• Roel Bakx, MD PhD

  Pediatric Surgical Center of Amsterdam (VUmc & AMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: drs.

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: July 29, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

NL (15)