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临床试验/NCT00687570
NCT00687570已完成不适用

Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Bowel purity degree

研究概览

简要总结

Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem.

Cleaning the bowel without complications for the patient is one of the aims for this study.

The other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.

详细描述

In our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment.

The actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. Nutritional drinks are to be used instead of traditional bowel preparation. Patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, Laxabon® (A) or nutritional drinks, Fresubin Energy drink (B) before surgery. Patients in subgroup B take nutritional drinks seven days before surgery instead of ordinary food. Bowel purity degree is measured peroperatively.

The secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. For four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup B (Fresubin Energy drink 15-30 kcal/kg*day). Subgroup A only eats ordinary food throughout the same period, before surgery.

Bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. All patients in the study keep records of physical activity daily, and food diary twice a week. Complications are registered.

Blood samples for hormones and electrolytes are taken before and after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • rectal cancer
  • age 18-90 years

排除标准

  • acute ileus
  • seriously dementia
  • metastatic disease

研究组 & 干预措施

A

Other

Traditional bowel preparation with Laxabon®

干预措施: Laxabon® (Drug)

B

Other

Nutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon®

干预措施: Fresubin Energy Drink (Dietary Supplement)

结局指标

主要结局

Bowel purity degree

时间窗: day of surgery

次要结局

  • Nutritional status(before and after operation)
  • Complications(day of surgery and days after surgery)
  • physiological function(before and after surgery)

研究者

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

Ulf Gustafsson

PhD, MD

Karolinska Institutet

研究点 (1)

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