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Trial registered on ANZCTR


Registration number
ACTRN12611000317998
Ethics application status
Approved
Date submitted
6/02/2011
Date registered
25/03/2011
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Among neonates with necrotizing enterocolitis does stoma versus intestinal anastomosis affect the time to full feeds and recovery: the STAT trial (SToma versus Anastomosis Trial)
Scientific title
Among neonates with necrotizing enterocolitis does stoma versus intestinal anastomosis affect the time to full feeds and recovery
Secondary ID [1] 253467 0
ISRCTN01700960
Universal Trial Number (UTN)
Trial acronym
STAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Necrotizing enterocolitis 261020 0
Condition category
Condition code
Surgery 259159 259159 0 0
Surgical techniques
Reproductive Health and Childbirth 259479 259479 0 0
Complications of newborn
Oral and Gastrointestinal 259480 259480 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anastomosis versus stoma formation.
Both procedures are used in standard surgical practice for necrotizing enterocolitis, the choice (in babies meeting the inclusion criteria of the present study) is determined by the surgeon's preference. Allocation of the terms "intervention" and "comparator" are therefore arbitary; for this section we will discuss stoma under intervention and anastomosis under comparator.
The whole operation (including and anaesthetic, the cut to open up the abdomen, removal of the diseased bowel and dealing with the two ends) takes about 2-3 hours. After removing the diseased bowel, the two ends are joined together using stitches. A potential complication of an anastomosis is that it can leak and cause peritonitis or an abscess. This occurs uncommonly.
Intervention code [1] 257908 0
Treatment: Surgery
Comparator / control treatment
A stoma is an opening of bowel onto the skin. As for an anastomosis, the whole operation takes about 2-3 hours. After removing the diseased bowel either one or both of the cut ends are sewn to the skin so bowel contents can leak into a bag. Some surgeons think a stoma may be "safer" than an anastomosis because it should not leak. The A further operation later on when the baby's condition has improved is necessary to close the stoma. A stoma however can cause several complications itself, such as prolapse.
Control group
Active

Outcomes
Primary outcome [1] 262009 0
Duration of parenteral nutrition
Timepoint [1] 262009 0
Up to 1 year
Secondary outcome [1] 268939 0
Mortality
Timepoint [1] 268939 0
1, 3 and 6 months
Secondary outcome [2] 268940 0
Number and type of surgical procedures performed
Timepoint [2] 268940 0
Up to 1 year.
Data collection forms completed at 1, 6 and 12 month follow-ups.
Secondary outcome [3] 268941 0
Hospital stay.
Timepoint [3] 268941 0
Up to 1 year.
Data collection forms completed at 1, 6 and 12 month follow-ups.
Secondary outcome [4] 268942 0
Intestinal absorptive function: i) calorie intake enterally and parenterally; ii) weight gain; iii) time to full enteral feeds; iv) requirement for medication to slow intestinal transit time.
Timepoint [4] 268942 0
1 month and 6 months.
Data collection forms completed at 1and 6 month follow-ups.
Secondary outcome [5] 268943 0
Inflammatory status: C-reactive protein, blood counts
Timepoint [5] 268943 0
Daily from the time of entry into the study for 7 days.
These are routine tests performed in the Neonatal Intensive Care Unit. The results will be recorded on a Daily Records form.
Secondary outcome [6] 268944 0
Intestinal complications: a) stricture; b) anastomotic leak; c) prolapse of stoma; d) stoma necrosis; e) intestinal obstruction; f) high output stoma; g) recurrence of NEC
Timepoint [6] 268944 0
Up to 1 year.
Data collection forms completed at 1, 6 and 12 month follow-ups.
Secondary outcome [7] 268945 0
Wound complications (infection, incisional hernia, dehiscence)
Timepoint [7] 268945 0
Up to 1 year.
Data collection forms completed at 1, 6 and 12 month follow-ups.
Secondary outcome [8] 268946 0
Days on antibiotics, incidence of sepsis (positive blood culture), intraabdominal abscess requiring drainage or reoperation.
Timepoint [8] 268946 0
Up to 1 year.
Data collection forms completed at 1, 6 and 12 month follow-ups.
Secondary outcome [9] 268947 0
Intraventricular haemorrhage.
Timepoint [9] 268947 0
At enrolment and 2 weeks after randomization
Secondary outcome [10] 268948 0
Respiratory function.
Timepoint [10] 268948 0
This will be assessed by the need for assisted ventilation ie oxygen requirement, CPAP or intubation for ventilation.
Spirometry is not performed as a routine therefore will not be used to assess respiratory function in this study.
This will also be assessed (eg need for supplimentary oxygen) at 1, 3 and 6 months and 1 year.
Secondary outcome [11] 268949 0
Cost of hospital treatment to the hostital.
Timepoint [11] 268949 0
Up to 1 year
This will be calculated from standard measures including lenght of neonatal intensive care unit stay, length of total hospital stay, number of operations and number of interventions. These will be recorded on the data forms.
Secondary outcome [12] 268950 0
Time to death
Timepoint [12] 268950 0
Up to 1 year
Secondary outcome [13] 268951 0
Cause of death (related to abdominal sepsis / not related to abdomen [cardiac anomaly / cerebral haemorrhage / other]
Timepoint [13] 268951 0
Up to 1 year

Eligibility
Key inclusion criteria
1. suspected necrotizing enterocolitis
2. need for laparotomy based on
i) radiological signs of intestinal perforation or
ii) failure of improvement with medical treatment
Minimum age
No limit
Maximum age
3 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. no evidence of NEC
2. focal intestinal perforation
3. extensive NEC precluding intestinal anastomosis
4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding
5. pateint's instability during the operation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified by consultant paediatric surgeons and neonatologists. The paediatric surgeon will describe the trial to the neonate's parent(s)/care giver(s) at the time of getting consent for the study.
Randomization will be done on-line in theatre at the time of confirmation that both stoma and primary anastomosis are feasible. Theatre staff will login to the STAT trial website. The surgeon who invites the participant onto the trial and performs the surgery will be unaware of which group a patient will be allocated to at the time of determining eligability. The allocation occurs through a central computer at the Institute of Child Health in London.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated to groups by weighted minimization using the following criteria: Weight at enrolment; Mechanical ventilation required; Inotropic support required; Extent of disease; Intestine involved.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3156 0
New Zealand
State/province [1] 3156 0
Auckland

Funding & Sponsors
Funding source category [1] 258439 0
Hospital
Name [1] 258439 0
Auckland District Health Board
Address [1] 258439 0
Park Road
Private Bag 92024
Auckland 1140
Country [1] 258439 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Park Road
Private Bag 92024
Auckland 1140
Country
New Zealand
Secondary sponsor category [1] 257585 0
None
Name [1] 257585 0
Address [1] 257585 0
Country [1] 257585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260427 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 260427 0
C/- Ministry of Health
Montgomery Watson Building
6 Hazeldean Road
Christchurch 8024
New Zealand
Ethics committee country [1] 260427 0
New Zealand
Date submitted for ethics approval [1] 260427 0
01/03/2011
Approval date [1] 260427 0
24/08/2011
Ethics approval number [1] 260427 0

Summary
Brief summary
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.
Trial website
http://www.ucl.ac.uk/ich/research-ich/surgery/stat-trial
Trial related presentations / publications
Hall, Nigel J., Simon Eaton, and Agostino Pierro. "Necrotizing enterocolitis: prevention, treatment, and outcome." Journal of pediatric surgery 48, no. 12 (2013): 2359-2367.

Public notes

Contacts
Principal investigator
Name 32129 0
Dr James Hamill
Address 32129 0
Department of Surgery, Starship Children's Hospital,
Private Bag 92024
Auckland 1142
New Zealand
Country 32129 0
New Zealand
Phone 32129 0
+6421753081
Fax 32129 0
Email 32129 0
jamesh@adhb.govt.nz
Contact person for public queries
Name 15376 0
Dr James Hamill
Address 15376 0
Department of Paediatric Surgery and Urology
Starship Children's Hospital
Private Bag 92024
Auckland 1140
Country 15376 0
New Zealand
Phone 15376 0
+64 9 3074949 ext 6381
Fax 15376 0
+64 9 307 8952
Email 15376 0
jamesh@adhb.govt.nz
Contact person for scientific queries
Name 6304 0
Dr James Hamill
Address 6304 0
Department of Paediatric Surgery and Urology
Starship Children's Hospital
Private Bag 92024
Auckland 1140
Country 6304 0
New Zealand
Phone 6304 0
+64 9 3074949 ext 6381
Fax 6304 0
+64 9 307 8952
Email 6304 0
jamesh@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results