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临床试验/NCT04323696
NCT04323696Unknown不适用

Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy

Universiti Putra Malaysia0 个研究点目标入组 50 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Immediate and early post-operative complication

研究概览

简要总结

Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.

研究设计

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

盲法说明

This is a single blinded randomisation whereby the patient is not aware on the staple-line suturing reinforcement used. Suturing reinforcement of the staple-line is our standard of care in all laparoscopic sleeve gastrectomy patients

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion

排除标准

  • Age < 18 or > 65
  • BMI < 35 and > 60 kg/m2
  • American Society of Anesthesiologists (ASA) score > 3
  • Concurrent surgical procedure including:
  • ventral hernia repair
  • cholecystectomy
  • hiatal hernia repair with posterior cruroplasty
  • extensive lysis of adhesions
  • other procedures that mandate addition of 'trocar(s)' or 'feeding tube'

结局指标

主要结局

Immediate and early post-operative complication

时间窗: 0-30 days

Staple line bleeding

次要结局

  • Immediate and early post-operative complication(0-30 days)

研究者

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

Zubaidah Nor hanipah

Associate Professor Dr

Universiti Putra Malaysia

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