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临床试验/NCT03754907
NCT03754907Unknown不适用

Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia

Zunyi Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Treatment success rate

研究概览

简要总结

Neonatal intestinal atresia is the most difficult disease to apply stapled anastomosis. However, there are no high-quality clinical trial to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled and hand-sewn anastomosis in neonate with intestinal atresia.

详细描述

Intestinal anastomosis in neonates with intestinal atresia has traditionally been performed using the hand-sewn end-to-end approach. After the introduction of stapled functional end-to-end anastomosis (FEEA) in neonates and infants by Powell in 1995, the procedure is gradually being accepted among pediatric surgeons. When treating intestinal atresia, great discrepancy between diameters of the proximal and distal intestine caused by disuse atrophy are often observed, which may cause difficulties and complications. To overcome size discrepancy, proficiency in performing anastomosis is required when using hand-sewn techniques. in theory, stapled functional end-to-end anastomosis does not require a special technique and does not impair the passage of intestinal contents immediately after completion because the side-to-side nature of the procedure retains the unique diameter of the target intestine and preserves patency. Stapled side-to-side functional end-to-end intestinal anastomosis is a potentially useful technique that is not affected by intestinal size discrepancy and does not require specialized surgical experience.To date, there have been a few studies about the safety and efficacy of stapled anastomosis in neonates and infants, which reported the efficacy of stapled over hand-sewn anastomosis, including shorter operative time, time to full feeding and hospitalization, and no difference in adverse outcomes between both types of anastomoses. These studies compared the clinical outcomes in neonates and infants. However,there are no high-quality clinical trials to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled FEEA and hand-sewn anastomosis in neonate with intestinal atresia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Patients were eligible if they were between 1 day and 30 days of age, and if they suffered from intestinal atresia.

排除标准

  • These patients were complicated with intestinal perforation and peritonitis, instability of vital signs.
  • Stapled anastomosis could not be performed when the intestinal lumen could not admit a 22-Fr soft catheter.

研究组 & 干预措施

stapled anastomosis group

Experimental

Following the first side-to-side anastomosis at the antimesenteric border in both intestinal limbs, the staple lines are oversewn to reinforce the crotch. Thereafter, the stapler is again fired across the joined intestinal limbs to close the enterotomies. The suture line of the side-to-side anastomosis should not overlap, and the staple lines are oversewn to reinforce the double-stapled areas.

干预措施: Endocutter stapler (Procedure)

hand-sewn anastomosis group

Active Comparator

Patients chose HA group will performed in an end-to-end manner using absorbable suture material.

干预措施: suture material (Procedure)

结局指标

主要结局

Treatment success rate

时间窗: 1 year

Treatment success rate is defined as a patient successfully undergoing two respectively operative methods in two groups , resulting in discharge from the hospital without the need for reoperation intervention and no complication happened during a minimum follow-up of 1 year (treatment efficacy).

次要结局

  • Estimated blood loss(ml)(1 year)
  • Time to initial oral feeding(1 year)
  • volvulus(1 year)
  • Operative time(minute)(1 year)
  • ileus(1 year)
  • reoperation(1 year)
  • Time to full oral feeding(1 year)
  • anastomotic leakage and stricture(1year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

zebing Zheng

pediatric surgery

Zunyi Medical College

研究点 (1)

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