Welcome to the STAT Trial website.
The STAT Trial is an international, multicentre, prospective randomised controlled trial comparing intestinal resection with stoma formation or intestinal resection with primary anastomosis in the surgical management of neonates with necrotizing enterocolitis (NEC).
STAT stands for: Stoma or Intestinal Anastomosis for Necrotizing Enterocolitis of the Neonate.
The trial is an international collaboration designed to answer the question:
Which is the most effective operation for neonates with necrotizing enterocolitis (NEC): intestinal resection with stoma formation or intestinal resection with primary anastomosis?
STAT is a prospective randomised controlled trial with currently 10 participating centres internationally (UK, USA, Canada, Italy, Netherlands, Sweden, Serbia and Latvia).
The lead centre is the Institute of Child Health and Great Ormond Street Hospital for Children, London, UK.
With parental consent, 80 neonates with suspected NEC or need for laparotomy based on radiological signs of intestinal perforation or failure of improvement with medical treatment will be randomised at laparotomy to either stoma formation or primary anastomosis. The neonates will be monitored for the recovery of intestinal function after surgery for NEC by duration of parenteral nutrition (days).
Several secondary outcome measures will also be compared between the two treatment groups. (See STAT trial protocol for full details)
To randomise a new patient into the STAT Trial you will need the following:
- STAT trial login name and password for your centre
- All patient information from: Form A: Randomisation
- The patient must meet all the inclusion criteria and none of the exclusion criteria
- RANDOMISE A NEW PATIENT NOW
Download PDFs of all forms required for the STAT trial:
STAT trial protocol (PDF, 98 KB)
Inclusion / exclusion criteria (PDF, 11 KB)
Parent information sheet (PDF, 28 KB)
Consent form (PDF, 18 KB)
Randomisation (PDF, 23 KB)
Form A: Data Collection at Enrolment (PDF, 26 KB)
Form B: Daily Data Collection (PDF, 29 KB)
Form C: Patient Death (PDF, 19 KB)
Form D1: One month follow up (PDF, 20 KB)
From D2: Six months follow up (PDF, 20 KB)
Form D3: 1 Year follow up (PDF, 20 KB)
Form E: Operation Details (PDF, 30 KB)
Telephone: +44 (0)20 7905 2682
Fax: +44 (0)20 7404 6161
Department of Paediatric Surgery
Institute of Child Health and Great Ormond Street Hospital for Children
30 Guilford Street
London WC1N 1EH
- Great Ormond Street Hospital for Children & Institute of Child Health, London, UK
- Chelsea & Westminster Hospital, London, UK
- King’s College Hospital, London, UK
- The Hospital for Sick Children, Canada
- BC Children's Hospital, British Columbia, Canada
- Alberta Children’s Hospital, Canada
- Children's Hospital of Pittsburgh of UPMC
- Sophia’s Children’s Hospital, Netherlands
- University Children’s Hospital, Belgrade, Serbia
- Astrid Lindgren Children's Hospital/Karolinska University Hospital, Sweeden
- Children’s University Hospital, Riga, Latvia
Page last modified on 03 sep 10 12:16