STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial
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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.
Transcript
What's the best surgical approach for infants needing laparotomy for necrotizing enterocolitis, anaesthmosis, or stoma formation? I'm Lizzie Lee from Cincinnati Children's Hospital, and this is an article you should know about. The stat trial was a randomized controlled trial in 12 centers worldwide that looked at newborns who underwent laparotomy for necrotizing enterocolitis requiring intestinal resection from 2010 to 2020. They were randomized to two surgical approaches, either anasthmosis or stoma formation. They found that the infants undergoing primary anasthmosis had a significantly less duration of requiring parental nutrition compared to those with stoma formation without a difference in mortality or unplanned surgeries. This suggests that primary anasthmosis is superior for enhancing recovery from necrotizing enterocolitis in infants and does not increase adverse outcomes. Let us know what you think in the comments below and stay tuned for more articles that you should know about.