Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate

ISRCTN ISRCTN01700960
DOI https://doi.org/10.1186/ISRCTN01700960
Protocol serial number 09/H0713/58
Sponsor Great Ormond Street Hospital for Children NHS Trust (UK)
Funder Stanley Thomas Johnson Foundation (Switzerland)
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 of protocol

Not provided at time of registration

Contact information

Prof Agostino Pierro
Scientific

Nuffield Professor of Paediatric Surgery
Head of Surgery Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

+44 20 7242 9789
pierro.sec@ich.ucl.ac.uk

Study information

Primary study designInterventional
Study designMulticentre randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleStoma or intestinal anastomosis for necrotising enterocolitis of the neonate: a multicentre randomised controlled trial
Study acronymSTAT Trial
Study objectivesPrimary 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
Health condition(s) or problem(s) studiedNecrotising enterocolitis
InterventionThis 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 typeOther
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.

Key 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])

Completion date01/11/2013

Eligibility

Participant type(s)Patient
Age groupNeonate
SexAll
Target sample size at registration80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2010
Date of final enrolment01/11/2013

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Canada
  • Italy
  • Latvia
  • Netherlands
  • Serbia
  • Sweden
  • United States of America

Study participating centre

Nuffield Professor of Paediatric Surgery
London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

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

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