A Randomized Trial of Oral Protein Supplementation Following Non-bariatric Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Change in weight
研究概览
简要总结
Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •patients scheduled to undergo abdominal surgery [cholecystectomy, ventral hernia repair, colectomy, non-bariatric gastric surgery, appendectomy, small bowel resection, lysis of adhesions, liver resection, splenectomy, proctectomy, stoma construction, pancreatic surgery, duodenal surgery, adrenal surgery, renal surgery, or cystectomy]
排除标准
- •Age less than 18 years
- •Abdominal surgery within the past 6 months
- •Inability to attend follow-up appointments for at least 6 months
- •Liver failure (Child-Pugh Class B or C) or kidney failure (glomerular filtration rate (GFR) less than 30).
研究组 & 干预措施
Control
The patients in the control group did not receive any supplementation, and were directed to follow the dietary guidelines of their surgeon.
干预措施: Placebo (Other)
Treatment
Patients were instructed to consume one ounce (containing 16 grams of protein) of the supplement three times daily. No other modifications were made to the patient's diet. Patients were provided with a total of 60 doses, which would last 20 days if they consumed each dose as instructed.
干预措施: Prostat AWC (Dietary Supplement)
结局指标
主要结局
Change in weight
时间窗: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
Mean preoperative weight compared to mean postoperative weight at each follow-up appointment. Weight recorded in pounds, subsequent measurements at each postoperative point were normalized to the preoperative weight and reported as a relative percentage of the preoperative weight.
次要结局
- Change in white blood cell count (1x10 3/ uL)(Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months)
- Change in albumin (g/ dL)(Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months)
- Wound healing(Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months)
- Change in prealbumin (mg/ dL)(Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months)
- Change in total protein (g/ dL)(Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months)
研究者
Christina Riojas
Christina Riojas, General Surgeon
Eisenhower Army Medical Center