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
{"title":"STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial.","authors":"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","doi":"10.1007/s00383-024-05853-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19832,"journal":{"name":"Pediatric Surgery International","volume":"40 1","pages":"279"},"PeriodicalIF":1.5000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522064/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Surgery International","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00383-024-05853-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
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.
目的：STAT 试验是一项在全球 12 个中心开展的多中心随机对照试验，旨在确定对需要进行肠道切除术的坏死性小肠结肠炎（NEC）新生儿最有效的手术方法：造口形成（ST）或原位吻合（PA）：方法：因 NEC 而进行初次开腹手术的婴儿，如果手术医生认为 PA 或 ST 都是可行的治疗方案，则在术中随机选择 PA 或 ST。主要结果（肠外营养[PN]持续时间）通过 Cox 回归进行评估：从 2010 年到 2019 年，共招募了 80 名患者。接受吻合术的婴儿完成肠外营养的时间明显早于接受造口术的患者（危险比 PA vs. ST 2.38，95% CI 1.36-4.12 p = 0.004）。两组患者的死亡率无差异（PA 4/35 vs. ST 8/38 p = 0.35），需要进一步计划外手术的并发症发生率也无差异（p = n.s.）。与吻合组相比，造口组的多重肠道并发症发生率更高（ST 12/26 vs. PA 5/31，p = 0.02，费舍尔精确检验）：结论：在对 NEC 进行开腹手术时，如果切除肠道的远端没有病变，则应进行初级吻合术，因为它能促进 NEC 的恢复，降低出现多种肠道并发症的风险，并且不会增加不良后果。
期刊介绍：
Pediatric Surgery International is a journal devoted to the publication of new and important information from the entire spectrum of pediatric surgery. The major purpose of the journal is to promote postgraduate training and further education in the surgery of infants and children.
The contents will include articles in clinical and experimental surgery, as well as related fields. One section of each issue is devoted to a special topic, with invited contributions from recognized authorities. Other sections will include:
-Review articles-
Original articles-
Technical innovations-
Letters to the editor
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