Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial)
Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial)
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DOI：
10.1002/bjs.11389
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发表时间：
2019-12-17
影响因子：
9.6
通讯作者：
Targarona, E.
中科院分区：
文献类型：
--
作者：
Bollo, J.;Turrado, V.;Targarona, E.
背景一些非随机和回顾性研究表明，腹腔镜右半结肠切除术中结肠内吻合（IA）优于体外吻合（EA），但缺乏科学证据。目的是比较短期结果，并确定IA与EA相比在择期腹腔镜右半结肠切除术中的可能获益。方法2015年5月至2018年6月进行随机对照试验。主要终点是住院时间。次要终点为术中技术事件和术后临床结局。结果140例患者随机入组。IA组的手术持续时间长于EA组（中位数149（范围95-215）vs 123（60-240）min; P < 0，中心点001）。IA组的伤口长度较短（中位数6个中心点7（4-9个中心点5）vs 8个中心点7（5-13）cm; P < 0中心点0.001）。IA患者的消化功能恢复较早（中位数2中心点3与3中心点3天; P = 0中心点003），麻痹性肠梗阻的发生率较低（13%与30%; P = 0中心点022）。IA组需要较少的术后镇痛（平均值（s.d.）加权镇痛要求39（24）对53（26）; P = 0中心点001），疼痛评分也较低（P = 0中心点035）。术后血红蛋白水平的下降较小（平均值（s.d.）8个中心点8（1个中心点7）与17个中心点1（1个中心点7）mg/dl; P = 0中心点001），IA组的下消化道出血较少（3%与14%; P = 0中心点031）。IA与I级和II级并发症的发生率显著相关（分别为P = 0中心点016和P = 0中心点037）。IA组的住院时间略短（中位5个中心点7（范围2-19）vs 6个中心点6（2-23）天; P = 0中心点194）。结论两组患者住院时间相似，但IA组疼痛轻，并发症少。注册号：NCT 02667860（）。
Background Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy. Methods An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes. Results A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0 center dot 001). Wound length was shorter in the IA group (median 6 center dot 7 (4-9 center dot 5) versus 8 center dot 7 (5-13) cm; P < 0 center dot 001). Digestive function recovered earlier in patients with an IA (median 2 center dot 3 versus 3 center dot 3 days; P = 0 center dot 003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0 center dot 022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0 center dot 001) and the pain score was also lower (P = 0 center dot 035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8 center dot 8(1 center dot 7) versus 17 center dot 1(1 center dot 7) mg/dl; P = 0 center dot 001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0 center dot 031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0 center dot 016 and P = 0 center dot 037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5 center dot 7 (range 2-19) versus 6 center dot 6 (2-23) days; P = 0 center dot 194). Conclusion Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ().