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临床试验/NCT05816031
NCT05816031招募中不适用

Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients

Federico II University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Peri-operative complications

研究概览

简要总结

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. The study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.

详细描述

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. Due to a standard trans abdominal laparoscopic right adrenalectomy is performed with the patient in left lateral position, it is necessary to retract liver in order to expose the right adrenal gland and the cava vein. It is therefore evident how a reduced size liver may allow a faster, easier and safer surgery. Finding a normal size liver is uncommon in patients presenting with a body mass index above 30 Kg/m2. According to this, patients scheduled to right laparoscopic adrenalectomy and belonging to the case arm, will be administered a standard 21 days ketogenic diet before surgery. Conversely this will not be prescribed to patients belonging to control group. Ketogenic diet is based on a standard diet plus a ketogenic product to be taken once daily for 21 days. In both groups patients will undergo abdominal ultrasound before surgery.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 30 Kg/m2
  • Planned for laparoscopic right adrenalectomy
  • Age > 18y.o.
  • No contraindications for ketogenic diet

排除标准

  • Patients requiring conversion to open surgery
  • BMI < 30 Kg/m2
  • Age < 18 y.o.

结局指标

主要结局

Peri-operative complications

时间窗: Complications occurring during surgery and within 30 days from surgery

Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Musella MD

Professor

Federico II University

研究点 (1)

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