Soochow University Affiliated Children's Hospital, Pediatric Research Institute of Soochow University, Suzhou, P.R. China.
Department of Pediatric Surgery, Affiliated Hospital of Zunyi Medical University, Zunyi, P.R. China.
J Laparoendosc Adv Surg Tech A. 2022 Jun;32(6):696-701. doi: 10.1089/lap.2021.0714. Epub 2022 Apr 11.
The purpose of this study was to compare the safety and efficacy of hand-sewn versus stapled anastomosis therapy in intestinal atresia neonatal patients. This was a prospective randomized controlled trial in which 90 neonates with intestinal atresia were randomly divided into the hand-sewn group and the stapled group. All patients were assigned to undergo intestinal anastomosis by hand-sewn or stapler. The primary outcome measure was to analyze the anastomotic complications between groups. The secondary outcome measures were operative time, blood loss, length to initial feeds, length to full feeds, length of hospital stay, the incidence of bowel obstruction, reoperation and mortality, and weight and height 1 year after operation. A total of 82 patients were included (43 for hand-sewn and 39 for stapled group) for primary analysis. A total of 16 patients suffered from anastomotic complications in both groups. The incidence rate of anastomotic complications in the stapled group was significantly lower than that of the hand-sewn group (27.9% versus 10.3%, = .044). There were no differences in anastomotic leak, stricture, and bleeding in the hand-sewn group compared with stapled group. The operative time in the hand-sewn group was longer than the stapled group ( < .001), the length to initial and full feeds in the stapled group was shorter than that of the hand-sewn group ( < .001). The length of hospital stay was significantly shorter in the stapled group than the hand-sewn group ( = .016). The bowel obstruction, reoperation, weight and height, and mortality had no differences between groups during follow-up. Study results demonstrate that stapled anastomosis is safe and effective for intestinal atresia with distal diameter >1 cm, as it can decrease the incidence of anastomotic complications. However, the risk of anastomotic failure should be considered among type III b atresia. Clinical Trial Registration number: NCT03754907.
本研究旨在比较手工缝合与吻合器吻合治疗肠闭锁新生儿的安全性和疗效。这是一项前瞻性随机对照试验,将 90 例肠闭锁新生儿随机分为手工缝合组和吻合器组。所有患者均行肠吻合术,分别采用手工缝合或吻合器吻合。主要观察指标为分析两组吻合口并发症。次要观察指标为手术时间、出血量、开始喂养时间、完全喂养时间、住院时间、肠梗阻发生率、再次手术率和死亡率,以及术后 1 年体重和身高。共有 82 例患者(手工缝合组 43 例,吻合器组 39 例)纳入主要分析。两组共有 16 例患者发生吻合口并发症。吻合器组吻合口并发症发生率明显低于手工缝合组(27.9%比 10.3%, = .044)。吻合器组吻合口漏、狭窄和出血与手工缝合组比较,差异无统计学意义。手工缝合组手术时间长于吻合器组( < .001),吻合器组开始和完全喂养时间短于手工缝合组( < .001)。吻合器组住院时间明显短于手工缝合组( = .016)。随访期间两组肠梗阻、再次手术、体重和身高及死亡率差异无统计学意义。研究结果表明,对于远端直径>1 cm 的肠闭锁,吻合器吻合安全有效,可降低吻合口并发症发生率。然而,对于 IIIb 型闭锁,应考虑吻合口失败的风险。临床试验注册号:NCT03754907。