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Randomized Controlled Trial
. 2024 Oct 29;40(1):279.
doi: 10.1007/s00383-024-05853-3.

STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial

Simon Eaton  1 , Niloofar Ganji  2 , Mandela Thyoka  3 , Maher Shahroor  4 , Augusto Zani  4 , Hazel Pleasants-Terashita  4 , Ali El Ghazzaoui  4 , Jayaram Sivaraj  3 , Stavros Loukogeorgakis  3 , Paolo De Coppi  3 , Sandra Montedonico  5 , Sanja Sindjic-Antunovic  6 , Marija Lukac  6 , James Hamill  7 , Candy Suet Cheng Choo  8 , Shireen Anne Nah  8 , Jan Hulscher  9 , Sherif Emil  10 , Aigars Petersen  11 , Rene Wijnen  12 , Cornelius Sloots  12 , David Sigalet  13 , Edward Kiely  14 , Jan F Svensson  15 , Tomas Wester  15 , Agostino Pierro  16
Affiliations
Randomized Controlled Trial

STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial

Simon Eaton et al. Pediatr Surg Int. .

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.

Keywords: Anastomosis; Mortality; Necrotizing enterocolitis; Parenteral nutrition; Resection; Stoma.

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Conflict of interest statement

No conflict of interest has been declared by the authors in relation to the study itself.

Figures

Fig. 1
Fig. 1
STAT trial flow chart according to Consort guidelines1
Fig. 2
Fig. 2
Cox regression analysis of time on parenteral nutrition. Time on parenteral nutrition was compared between groups by Cox regression analysis, adjusting for inotrope use, and censoring for last follow up or death. The graph shows estimated times on parenteral nutrition based on the model fit
Fig. 3
Fig. 3
Cox regression analysis of time to death. Survival was compared between groups by Cox regression analysis, adjusting for inotrope use, and censoring for last follow up. The graph shows estimated survival times based on the model fit
See this image and copyright information in PMC

References

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    1. Chong C, van Druten J, Briars G, Eaton S, Clarke P, Tsang T, Yardley I (2019) Neonates living with enterostomy following necrotising enterocolitis are at high risk of becoming severely underweight. Eur J Pediatr 178:1875–1881. 10.1007/s00431-019-03440-6 - PMC - PubMed
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    1. Ade-Ajayi N, Kiely E, Drake D, Wheeler R, Spitz L (1996) Resection and primary anastomosis in necrotizing enterocolitis. J R Soc Med 89:385–8. 10.1177/014107689608900708 - PMC - PubMed

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