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临床试验/NCT04891822
NCT04891822已完成不适用

Enhanced Recovery After Bariatric Surgery(ERAS) in the Morbidly Obese Using Evidence-Based Clinical Pathways: A Prospective Observational Non-randomized Comparative Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Functional hospital stay

研究概览

简要总结

Recently, the number of bariatric surgery is increasing but ERAS (Enhanced Recovery After Surgery) protocol for bariatric surgery needs revision with evidence. So we investigated usefulness of ERAS protocol for bariatric surgery in morbidly obese patients.

详细描述

Patients undergoing elective laparoscopic bariatric surgery are going to be recruited and divided into 2 groups: Group E will receive ERAS protocol, and Group C will receive standard perioperative care.

ERAS protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery, TIVA(Total intra-venous anesthesia), TAP(transversus abdominis plane) block and IV-PCA using NSAIDs after surgery, and resumption of oral intake 2 hour after surgery.

Conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, IV-PCA using NSAIDs, and resumption oral intake 6 hour after surgery.

In both groups, gastric ultrasonography will be used to measure gastric volume before surgery.

Functional hospital stay will be recorded from the end of surgery until all discharge criteria had been met. Pain scores will be recorded at 30 minutes, 4 hours, and 24 hours after surgery. Also, nausea and vomiting, time to ambulation, will be documented. After the patients are discharged, their charts are going to be reviewed and their medical expenses will be documented.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists grade 1 ~ 3
  • BMI(Body Mass Index) ≥30
  • Scheduled for elective laparoscopic bariatric surgery

排除标准

  • American Society of Anesthesiologists grade 4 or 5
  • History of abdominal surgery

结局指标

主要结局

Functional hospital stay

时间窗: from end of surgery, until all discharge criteria had been met (an average of 3 days)

time from the end of surgery until all discharge criteria had been met

次要结局

  • Time to ambulation(Time to ambulation (an average of 1 day))
  • Postoperative Pain score(30 minutes, 4 hours, and 24 hours after end of surgery)
  • Postoperative nausea and vomiting(until patient discharge (an average of 3 days))
  • Medical expenses(until patient discharge (an average of 4 days))
  • Rescue drug and dosage(30 minutes, 4 hours, and 24 hours after end of surgery)

研究者

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

BON WOOK KOO

assistnat professor

Seoul National University Bundang Hospital

研究点 (1)

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