Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery.
详细描述
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient and the epidemiology nurse will not know the treatgment assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >40 Kg/m2 or >35 Kg/m2 associated to obesity-related comorbidities
- •Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
- •Patients accepting to participate in the study and signing and Informed Consent form
排除标准
- •Patients undergoing other bariatric techniques
- •Patients undergoing Roux-en-Y gastric bypass as revisional procedure
研究组 & 干预措施
Vitamin E acetate
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
干预措施: Vitamine E Acetate (Drug)
Control group
No ointment will be applied
干预措施: No application of vitamin E acetate (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 24 hours after surgery
Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche