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11 February 2012
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| [ Print-friendly version ] |
| Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate |
| ISRCTN | ISRCTN01700960 |
| ClinicalTrials.gov identifier | |
| Public title | Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate |
| Scientific title | Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate: a multicentre randomised controlled trial |
| Acronym | STAT Trial |
| Serial number at source | 09/H0713/58 |
| Study hypothesis |
Necrotising enterocolitis (NEC) is a devastating disease of babies' intestine which is associated with high mortality. The incidence of the disease is increasing in parallel with greater survival of premature babies. Babies with advanced NEC need surgery and it is not clear which is the best operation for them. After the removal of the intestine affected by NEC, some surgeons perform a stoma: an opening is made to the bowel from the skin and stool is collected into a bag; other surgeons prefer instead perform an anastomosis which requires the joining of the two ends of the intestine. Each operation has advantages and disadvantages. This trial will establish which is the best operation (i.e. stoma or anastomosis) to enhance the recovery of the intestine and improve survival.
The hypothesis to be tested is that 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. As of 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 |
| Lay summary | |
| Ethics approval | Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee approved on the 7th October 2009 (ref: 09/H0713/58). All other centres will seek ethics approval before recruiting participants. |
| Study design | Multicentre randomised controlled trial |
| Countries of recruitment | Canada, Italy, Latvia, Netherlands, Serbia, Sweden, United Kingdom, United States of America |
| Disease/condition/study domain | Necrotising enterocolitis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2010 |
| Anticipated end date | 01/11/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
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). |
| Primary outcome measure(s) | 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 measure(s) |
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]) |
| Sources of funding | Stanley Thomas Johnson Foundation (Switzerland) |
| Trial website | http://www.ich.ucl.ac.uk/ich/academicunits/Surgery/CustomMenu_01 |
| Publications | |
| Contact name | Prof Agostino Pierro |
| Address |
Nuffield Professor of Paediatric Surgery
Head of Surgery Unit Institute of Child Health 30 Guilford Street |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| pierro.sec@ich.ucl.ac.uk | |
| Sponsor | Great Ormond Street Hospital for Children NHS Trust (UK) |
| Address |
Research and Development Office
30 Guilford Street |
| City/town | London |
| Zip/Postcode | WC1N 1EH |
| Country | United Kingdom |
| Sponsor website: | http://www.ich.ucl.ac.uk/research_and_development/ |
| Date applied | 19/01/2010 |
| Last edited | 24/08/2010 |
| Date ISRCTN assigned | 25/02/2010 |
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