EBNEO COMMENTARY: Stoma or Intestinal Anastomosis for Necrotizing Enterocolitis

Caitlin Eason, S. Christopher Derderian review the paper "Eaton S, Ganji N, Thyoka M, Shahroor M, Zani A, Pleasants-Terashita H, Ghazzaoui AE, Sivaraj J, Loukogeorgakis S, De Coppi P, Montedonico S, Sindjic-Antunovic S, Lukac M, Hamill J, Choo CSC, Nah SA, Hulscher J, Emil S, Petersen A, Wijnen R, Sloots C, Sigalet D, Kiely E, Svensson JF, Wester T, Pierro A. STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial. Pediatr Surg Int. 2024 Oct 29;40(1):279. PMID: 39470842." for EBNEO October 2024 Article of the Month.

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ACTA COMMENTARY:

Acta Paediatrica - 2025 - Eason - EBNEO COMMENTARY Stoma or Intestinal Anastomosis for Necrotizing Enterocolitis.pdf

"An estimated 42% of infants with NEC will require surgery for necrotic bowels. It was unknown whether resection with stoma creation or primary anastomosis resulted in better outcomes.1 The STAT trial compared the efficiency of intestinal recovery between these operative interventions and the primary outcome was parenteral nutrition (PN).

Primary anastomosis following a resection remains low (15.8%) in patients with NEC, despite evidence that it is a suitable surgical intervention.2-5 However, it is difficult to evaluate retrospective studies due to inherent bias, because those receiving a primary anastomosis may be less sick than those requiring enterostomy. This trial aimed to minimize this bias by randomizing infants with NEC who could have reasonably had either operation.

The STAT trial methodology highlights the challenges of comparing primary anastomosis to enterostomy, because the inclusion criteria were based on the subjective determination that either operation was appropriate. This compromised generalizability, because it depended on the surgeons’ judgement. Moreover, it is unclear why a surgeon would opt for a stoma when either operation was appropriate. It would be beneficial to obtain information about the surgeons’ decisions to perhaps establish protocols for such an ambiguous decision-making process. Furthermore, it took nearly a decade to recruit 79 patients across 10 centers. Details about those judged ineligible would have been valuable, but the baseline characteristics were similar between the groups. However, more patients in the stoma group required mechanical ventilation.

The primary outcome, of PN duration, was predictably shorter in the primary anastomosis group, as intestinal continuity was maintained. PN is associated with several risk factors, including liver disease, electrolyte imbalances and central line-associated blood stream infections.6 These factors, and infant growth, were not evaluated as additional outcomes and may have provided clinically relevant support for anastomosis than simply PN duration.

The main differences in secondary outcomes between the primary anastomosis and stoma groups were multiple intestinal complications and those related to the stoma. As expected, the stoma group had more stoma-related issues. Multiple intestinal complications were not explicit, making this difference rather obscure. We assumed that this higher rate of multiple complications indicated a more complex postoperative course. However, it was difficult to tell without knowing the combination of complications and the differences in additional abdominal operations. In addition, the study was probably underpowered to detect significant differences in secondary outcomes.

Differences in intestinal complications and PN duration, in conjunction with similar mortality, support the need to evaluate length of stay. This could hypothetically be longer for the enterostomy group, due to the need for more healthcare resources for multiple complications and PN.

The STAT trial findings support primary anastomosis in infants with NEC that require a laparotomy, if surgeons judge this to be safe and feasible. Such operations would probably reduce PN duration and decrease risks of multiple postoperative intestinal complications. Future research should focus on the parameters and protocols involved in these surgical decisions and evaluate the clinically significant results of such outcomes including infant growth, PN risks and length of stay."