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国际系列横结肠成形术数据登记处的首次报告:适应证、疗效及并发症

First report of the international serial transverse enteroplasty data registry: indications, efficacy, and complications.

作者信息

Modi Biren P, Javid Patrick J, Jaksic Tom, Piper Hannah, Langer Monica, Duggan Christopher, Kamin Daniel, Kim Heung Bae

机构信息

Center for Advanced Intestinal Rehabilitation, Children's Hospital Boston and Harvard Medical School, Boston, MA 02115, USA.

出版信息

J Am Coll Surg. 2007 Mar;204(3):365-71. doi: 10.1016/j.jamcollsurg.2006.12.033.

DOI:10.1016/j.jamcollsurg.2006.12.033
PMID:17324769
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3217837/
Abstract

BACKGROUND

Serial transverse enteroplasty (STEP) is a novel surgical therapy for short bowel syndrome and is being used with increasing frequency worldwide. Because no single center is likely to obtain sufficient experience for meaningful analysis, we created the International STEP Data Registry to allow for larger, multicenter patient accrual and followup. This report describes patient characteristics, operative parameters, and early results of STEP in the first 38 patients enrolled in the International STEP Data Registry.

STUDY DESIGN

After IRB approval, data were entered online through password-protected enrollment and followup forms. Patient and procedural characteristics were analyzed. Pre- and postoperative small bowel length and enteral feeding tolerance were compared with the paired t-test.

RESULTS

Between September 1, 2004, and April 30, 2006, 19 centers from 3 countries enrolled 38 patients. Median followup from STEP procedure to analysis was 12.6 months (range 0 to 66.9 months). Indications for STEP were short bowel syndrome (SBS, n=29), bacterial overgrowth (n=6), and neonatal atresia (n=3). Mean small intestine length was substantially increased in all groups (68+/-44 cm versus 115+/-87 cm, p < 0.0001, n=27). Notable complications included intraoperative staple line leak (n=2), bowel obstruction (n=2), and fluid collection or abscess (n=3). Late outcomes included progression to transplantation (n=3) and mortality (n=3). For the short bowel syndrome cohort, enteral tolerance was notably increased from 31%+/-31% to 67%+/-37% of calories (p < 0.01, n=21).

CONCLUSIONS

STEP has been performed at multiple centers with minimal complications and encouraging outcomes. Indications for the procedure have broadened beyond short bowel syndrome to include bacterial overgrowth and neonatal intestinal obstruction with dilated proximal intestine. Continued accrual and followup of patients in the International STEP Data Registry will elucidate the longterm safety and efficacy of the procedure, with the goal of improved patient selection and operative timing.

摘要

背景

系列横断肠成形术(STEP)是一种用于治疗短肠综合征的新型手术疗法,在全球范围内的应用频率日益增加。由于单个中心可能难以积累足够的经验进行有意义的分析,我们创建了国际STEP数据注册库,以便进行更大规模的多中心患者招募和随访。本报告描述了国际STEP数据注册库中首批38例患者的患者特征、手术参数和早期结果。

研究设计

经机构审查委员会(IRB)批准后,通过受密码保护的注册和随访表格在线输入数据。对患者和手术特征进行了分析。采用配对t检验比较术前和术后小肠长度及肠内喂养耐受性。

结果

在2004年9月1日至2006年4月30日期间,来自3个国家的19个中心招募了38例患者。从STEP手术到分析的中位随访时间为12.6个月(范围0至66.9个月)。STEP的适应证包括短肠综合征(SBS,n = 29)、细菌过度生长(n = 6)和新生儿闭锁(n = 3)。所有组的平均小肠长度均显著增加(68±44 cm对115±87 cm,p < 0.0001,n = 27)。显著的并发症包括术中吻合钉线漏(n = 2)、肠梗阻(n = 2)和积液或脓肿(n = 3)。晚期结局包括进展为移植(n = 3)和死亡(n = 3)。对于短肠综合征队列,肠内耐受性从热量的31%±31%显著增加至67%±37%(p < 0.01,n = 21)。

结论

多个中心已开展STEP手术,并发症极少,结果令人鼓舞。该手术的适应证已从短肠综合征扩展至包括细菌过度生长和近端肠管扩张的新生儿肠梗阻。国际STEP数据注册库中患者的持续招募和随访将阐明该手术的长期安全性和有效性,目标是改善患者选择和手术时机。

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