Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate
| ISRCTN | ISRCTN01700960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01700960 |
| Secondary identifying numbers | 09/H0713/58 |
- Submission date
- 19/01/2010
- Registration date
- 25/02/2010
- Last edited
- 06/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Agostino Pierro
Scientific
Scientific
Nuffield Professor of Paediatric Surgery
Head of Surgery Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 20 7242 9789 |
|---|---|
| pierro.sec@ich.ucl.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate: a multicentre randomised controlled trial |
| Study acronym | STAT Trial |
| Study hypothesis | Primary anastomosis after intestinal resection offers significant advantages to neonates with NEC including more rapid recovery of the intestine and therefore shorter duration of time to full feeding. |
| Ethics approval(s) | Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee, 07/10/2009, ref: 09/H0713/58 |
| Condition | Necrotising enterocolitis |
| Intervention | This will be a multicentre randomised controlled trial which means that 80 neonates (40 in each arm) will be allocated to receive one of these two types of operations which are both valid and used routinely: 1. Intestine attached to the skin (stoma formation), or 2. Removal of the diseased gut and joining of the healthy ends (primary anastomosis) Both of these types of operation are currently performed for infants with NEC. Before performing the operation to open the abdomen (laparotomy) parents or care giver of the affected neonate will be asked consent for inclusion in the trial. At laparotomy the surgeon will ascertain the presence of NEC and will assess the extent of the disease. He/she will determine if the infant is eligible (dependent on the listed inclusion/exclusion criteria) and will allocate the child to receive one of the two operations online using the internet or using a sealed envelope as a backup system. There will be no other research investigations for participants in the study. Clinical information will be collected from medical and nursing records during the stay in hospital and in clinic (if the patient has been discharged from the hospital) at 1, 3 and 6 months after starting the study. The end of follow-up is at 3 years (for neurodevelopmental outcomes). |
| Intervention type | Other |
| Primary outcome measure | Duration of parenteral nutrition (days), as this reflects the recovery of intestinal function after NEC and will be affected by complications and/or need for further procedures. |
| Secondary outcome measures | 1. Mortality at 1, 3 and 6 months after randomisation 2. Number and type of surgical procedures performed (including insertion of central venous lines) 3. Hospital stay (days) for survivors and non-survivors 4. Intestinal absorptive function. This will be assessed by measuring: 4.1. Calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomisation 4.2. Weight gain at 1 month and 6 months after randomisation 4.3. Time (days) to full enteral feeding 4.4. Requirement for medication to slow intestinal transit time 5. Intestinal complications: 5.1. Stricture (of either anastomosis or remaining intestine, confirmed by a contrast study and/or histology) 5.2. Anastomotic leak 5.3. Prolapse of stoma 5.4. Stoma necrosis 5.5. Intestinal obstruction 5.6. High output stoma 5.7. Recurrence of NEC 6. Wound complication (infection, incisional hernia, dehiscence) 7. Days on antibiotics, incidence of sepsis (positive blood culture), intra-abdominal abscess requiring drainage or reoperation 8. Intraventricular haemorrhage (ultrasound scan of the brain at enrolment in the trial and 2 weeks after randomisation). Intraventricular haemorrhages will be graded (grade I to IV) according to their extent and severity. 9. Respiratory function. This will be assessed by recording the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomisation 10. Cost of hospital treatment 11. Time to death (days) 12. Cause of death (related to abdominal sepsis/not related to abdomen [cardiac anomaly/cerebral haemorrhage/other]) |
| Overall study start date | 01/02/2010 |
| Overall study end date | 01/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | 1. Suspected NEC 2. Need for laparotomy based on: 2.1. Radiological signs of intestinal perforation or 2.2. Failure of improvement with medical treatment 3. Aged 0 - 6 months, either sex |
| Participant exclusion criteria | 1. No evidence of NEC (e.g. intestinal volvulus) 2. Focal intestinal perforation (since many surgeons would not perform a stoma) 3. Extensive NEC precluding intestinal anastomosis (intestinal resection will result in short bowel) 4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding 5. Patient's instability during the operation |
| Recruitment start date | 01/02/2010 |
| Recruitment end date | 01/11/2013 |
Locations
Countries of recruitment
- Canada
- England
- Italy
- Latvia
- Netherlands
- Serbia
- Sweden
- United Kingdom
- United States of America
Study participating centre
Nuffield Professor of Paediatric Surgery
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Great Ormond Street Hospital for Children NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Website | http://www.gosh.nhs.uk/research-and-innovation/ |
|---|---|
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Charity
Stanley Thomas Johnson Foundation (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/09/2016: No publications found in PubMed, verifying study status with principal investigator.
24/08/2010: This record has been updated to include amended anticipated trial dates; the initial anticipated trial dates were as follows:
Initial anticipated start date: 01/11/2010
Initial anticipated end date: 01/11/2012
