Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial
Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial
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DOI：
10.1097/sla.0b013e318176bf81
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发表时间：
2008-07-01
影响因子：
9
通讯作者：
Pierro, Agostino
中科院分区：
文献类型：
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作者：
Rees, Clare M.;Eaton, Simon;Pierro, Agostino
目的：为了确定原发性腹膜引流是否能改善极低出生体重儿（ELBW）肠穿孔婴儿的生存率和预后，背景资料：ELBW肠穿孔婴儿的最佳手术治疗尚不清楚。入选标准为出生体重>= 1000 g，X线检查显示有气腹（坏死性结肠炎或孤立性穿孔）。患者被随机分配至腹腔引流或剖腹手术，尽量减少体重、妊娠、通气、正性肌力药、血小板、国家和现场手术设施的差异。随机分配至引流的患者在至少12小时无临床改善后允许延迟剖腹手术。结果：69例患者被随机分组（35例引流，34例剖腹手术）;我随后撤回了知情同意书。6个月生存率为18/35例（51.4%）引流术和21/33例（63.6%）剖腹手术（P = 0.3;差异12%95%CI，-11，34%）。考克斯回归分析显示两组之间无显著差异（引流管风险比为1.6; P = 0.3; 95% CI，0.7-3.4）。26/35例（74%）患者在中位时间2.5天（范围，0.4-21天）后进行了延迟剖腹手术，与初次剖腹手术相比，延迟剖腹手术并未改善6个月生存率（死亡率的相对风险为1.4; P = 0.4; 95%CI，0.6-3.4）。引流是有效的，作为一个明确的治疗只有4/35（11%）存活的新生儿，其余的要么延迟剖腹手术或dead.Conclusions：74%的新生儿治疗原发性腹膜引流需要延迟剖腹手术。两个随机分组之间的结局无显著差异。原发性腹膜引流作为一种临时措施或确定性治疗是无效的。如果插入引流管，应考虑及时进行“抢救性”剖腹手术。
Objective: To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation.Summary Background Data: Optimal surgical management of ELBW infants with intestinal perforation is unknown.Methods: An international multicenter randomized controlled trial was performed between 2002 and 2006. Inclusion criteria were birthweight >= 1000 g and pneumoperitoneum on x-ray (necrotizing enterocolifis or isolated perforation). Patients were randomized to peritoneal drain or laparotomy, minimizing differences in weight, gestation, ventilation, inotropes, platelets, country, and on-site surgical facilities. Patients randomized to drain were allowed to have a delayed laparotomy after at least 12 hours of no clinical improvement. Results: Sixty-nine patients were randomized (35 drain, 34 laparotomy); I subsequently withdrew consent. Six-month survival was 18/35 (51.4%) with a drain and 21/33 (63.6%) with laparotomy (P = 0.3; difference 12% 95% CI, -11, 34%). Cox regression analysis showed no significant difference between groups (hazard ratio for primary drain 1.6; P = 0.3; 95% CI, 0.7-3.4). Delayed laparotomy was performed in 26/35 (74%) patients after a median of 2.5 days (range, 0.4-21) and did not improve 6-month survival compared with primary laparotomy (relative risk of mortality 1.4; P = 0.4; 95% CI, 0.6-3.4). Drain was effective as a definitive treatment in only 4/35 (11%) surviving neonates, the rest either had a delayed laparotomy or died.Conclusions: Seventy-four percent of neonates treated with primary peritoneal drainage required delayed laparotomy. There were no significant differences in outcomes between the 2 randomization groups. Primary peritoneal drainage is ineffective as either a temporising measure or definitive treatment. If a drain is inserted, a timely "rescue" laparotomy should be considered.