Condition category
Pregnancy and Childbirth
Date applied
19/01/2010
Date assigned
25/02/2010
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ucl.ac.uk/ich/research-ich/surgery/stat-trial

Contact information

Type

Scientific

Primary contact

Prof Agostino Pierro

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/H0713/58

Study information

Scientific title

Stoma or intestinal anastomosis for necrotising enterocolitis of the neonate: a multicentre randomised controlled trial

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

Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee, 07/10/2009, ref: 09/H0713/58

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2010

Overall trial end date

01/11/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

80

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, Italy, Latvia, Netherlands, Serbia, Sweden, United Kingdom, United States of America

Trial participating centre

Nuffield Professor of Paediatric Surgery
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children NHS Trust (UK)

Sponsor details

Research and Development Office
30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Government

Website

http://www.gosh.nhs.uk/research-and-innovation/

Funders

Funder type

Charity

Funder name

Stanley Thomas Johnson Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

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