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临床试验/NCT04644445
NCT04644445Unknown不适用

Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting

Thomas Jefferson University4 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年11月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
112
试验地点
4
主要终点
Postoperative nausea and vomiting related delay in hospital discharge

研究概览

简要总结

Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. This study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.

详细描述

Patients with obesity or morbid obesity who are scheduled to undergoing robotic or laparoscopic sleeve gastrectomy will be screened at their preoperative visit. If they meet inclusion/exclusion criteria, they will be invited to participate in the study and written informed consent will be obtained. If the patient consents to participation, they will be randomized to either the control arm or intervention arm. All patients will undergo sleeve gastrectomy in a standard fashion, either laparoscopically or robotically, as discussed with their bariatric surgeon. Post-operative diet will be initiated 4 hours after surgery. The specific diet received will depend on which arm the patient is randomized into. Post-operative assessments will be completed at various time points for all patients. These include a Verbal Rating Scale of Nausea and Vomiting, Rhodes Index Survey, and Quality of Recover-15 Survey. All patients will track their oral intake on a spreadsheet which will be provided. Additional demographic and clinical data will be collected from the Electronic Medical Record. After hospital discharge, patients will follow up in the clinic one week and one month after surgery, per routine. After the one-month visit, the patient's study participation will be considered complete.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Adult patient undergoing robotic or laparoscopic sleeve gastrectomy
  • Patient able to provide written informed consent
  • Patient able to understand and comply with study guidelines

排除标准

  • Inability to provide consent
  • Previous history of bariatric or gastroesophageal surgery
  • Chronic nausea/vomiting
  • Hemoglobin A1C 9 or higher
  • Therapeutic anticoagulation
  • Celiac disease or gluten sensitivity/intolerance/allergy

结局指标

主要结局

Postoperative nausea and vomiting related delay in hospital discharge

时间窗: through hospital discharge, an average of two days after surgery

Inability to be discharged from the hospital on postoperative day 1 due to postoperative nausea and vomiting. This will be measured by inability to maintain oral intake of 4-6 ounces an hour due to feeling of nausea or vomiting.

次要结局

  • Patient Self-Reported Quality of Recovery(Baseline until 1 month after surgery)
  • 30-Day Events(Up to 30 days after surgery)
  • Length of Stay(through hospital discharge, an average of two days after surgery)
  • Severity of Postoperative Nausea and Vomiting(Baseline until 1 month after surgery)
  • Cost of Hospital Stay(Up to 30 days after surgery)
  • Hospital Antiemetic Usage(through hospital discharge, an average of two days after surgery)
  • Weight Loss(Up to 30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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