STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial
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In brief
In brief
The STAT trial compared two surgical approaches for necrotizing enterocolitis requiring bowel resection in neonates across 12 centers. Primary anastomosis led to significantly faster recovery from parenteral nutrition and fewer intestinal complications compared to stoma formation, with no difference in mortality rates.
- Primary anastomosis reduces parenteral nutrition duration vs stoma in NEC requiring resection (HR 2.38, p=0.004)
- No mortality difference between primary anastomosis and stoma formation in neonatal NEC surgery
- Stoma formation associated with higher rate of multiple intestinal complications compared to primary anastomosis
- When distal bowel is healthy at NEC laparotomy, primary anastomosis is preferred over stoma creation
- Primary anastomosis enhances recovery without increasing adverse outcomes in appropriately selected NEC cases
Written by the GCMD Library team from the article.
Abstract
Purpose
The STAT trial is a multicenter randomized controlled trial in 12 centers worldwide aiming to determine the most effective operation for neonates with necrotizing enterocolitis (NEC) requiring intestinal resection: stoma formation (ST) or primary anastomosis (PA).
Methods
Infants having a primary laparotomy for NEC were randomized intraoperatively to PA or ST if the operating surgeon thought that both were viable treatment options for that patient. The primary outcome (duration of parenteral nutrition [PN]) was evaluated by Cox regression.
Results
Eighty patients were recruited from 2010 to 2019. Infants undergoing anastomosis finished PN significantly earlier than patients undergoing stoma (hazard ratio PA vs. ST 2.38, 95% CI 1.36–4.12 p = 0.004). There was no difference in mortality between the two groups (PA 4/35 vs. ST 8/38 p = 0.35) or in the rate of complications requiring further unplanned operations (p = n.s.). Multiple intestinal complications were more frequent in the stoma group compared to the anastomosis group (ST 12/26 vs. PA 5/31, p = 0.02, Fisher’s Exact test).
Conclusion
At laparotomy for NEC, when there is no disease distal to resected intestine, primary anastomosis should be performed as it enhances the recovery from NEC, reduces the risk of multiple intestinal complications and does not increase adverse outcomes.