STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial
Infographic · Dec 2024 · 1 min read
In brief
In brief
Multicenter RCT of 80 infants with NEC requiring resection found primary anastomosis superior to stoma formation, with faster weaning from parenteral nutrition and fewer intestinal complications. No difference in mortality was observed between groups, supporting anastomosis as preferred approach when distal bowel is healthy.
- Primary anastomosis reduces parenteral nutrition duration vs stoma in NEC requiring resection (HR 2.38, p=0.004)
- Mortality rates are equivalent between primary anastomosis and stoma formation in NEC surgery
- Stoma formation increases risk of multiple intestinal complications compared to primary anastomosis (46% vs 16%, p=0.02)
- 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 patients
Written by the GCMD Library team from the infographic.
Simon Eaton, Niloofar Ganji, Mandela Thyoka, Maher Shahroor, Augusto Zani, Hazel Pleasants-Terashita, Ali El Ghazzaoui, Jayaram Sivaraj, Stavros Loukogeorgakis, Paolo De Coppi, Sandra Montedonico, Sanja Sindjic-Antunovic, Marija Lukac, James Hamill, Candy Suet Cheng Choo, Shireen Anne Nah, Jan Hulscher, Sherif Emil, Aigars Petersen, Rene Wijnen, Cornelius Sloots, David Sigalet, Edward Kiely, Jan F Svensson, Tomas Wester, Agostino Pierro
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.