STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial
Simon Eaton, Niloofar Ganji, Mandela Thyoka, Maher Shahroor, Augusto Zani, Hazel Pleasants-Terashita, Ali El Ghazzaoui, Jayaram Sivaraj, Stavros Loukogeorgakis, Paolo De Coppi, Sandra Montedónico, Sanja Sinđić-Antunović, Marija Lukač, James Hamill, Candy S. C. Choo, Shireen Anne Nah, Jan B.F. Hulscher, Sherif Emil, Aigars Petersen, Rene Wijnen, Cornelius E. J. Sloots, David L. Sigalet, Edward M. Kiely, Jan F. Svensson, Tomas Wester, Agostino Pierro
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.