None listed
Conditions
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.
Interventions
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
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.
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 3 Months
Healthy volunteers
No
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
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
Outcome results
None listed