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临床试验/NCT04442568
NCT04442568Unknown不适用

Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy

Umraniye Education and Research Hospital0 个研究点目标入组 100 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
发起方
入组人数
100
主要终点
length of hospital stay

研究概览

简要总结

Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are determined for ERAS. All patients will be checked for status of pain with VAS score, nausea and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral intake will be started in the morning of postoperative first day. The patients who provides discharge criterias will be discahrged. these criterias are; To provide adequate pain relief with paracetamol and nonsteroidal painkillers, No wound problem, No complications after surgery, Pulse rate <90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, <20 breaths / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.

Emergency admissions of the participants within a month after surgery will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be performed laparoscopic sleeve gastrectomy
  • body mass index > 35 with a comorbidıty or ,body mass index > 40

排除标准

  • surgery with peroperative complication
  • revision surgery applications

结局指标

主要结局

length of hospital stay

时间窗: till discharge, an average of 36 hours

the time (in hours) from the start of surgery to the discharge of patients in both groups

Score of Visual analog scale

时间窗: postoperative 24 hours

VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maxımum score 10 and higher scores mean a worse outcome)

number of emergency re-admission after surgery

时间窗: during postoperative first 30 days

number of emergency re-admission after surgery due to complications or patients discomfort

次要结局

未报告次要终点

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Abdullah Sisik

Assoc. Prof.

Umraniye Education and Research Hospital

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