Bowel Preparation Before Rectal Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687570
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : February 20, 2015
Information provided by (Responsible Party):
Ulf Gustafsson, Karolinska Institutet

May 28, 2008
June 2, 2008
February 20, 2015
July 2008
July 2014   (Final data collection date for primary outcome measure)
Bowel purity degree [ Time Frame: day of surgery ]
Same as current
Complete list of historical versions of study NCT00687570 on Archive Site
  • Nutritional status [ Time Frame: before and after operation ]
  • Complications [ Time Frame: day of surgery and days after surgery ]
  • physiological function [ Time Frame: before and after surgery ]
Same as current
Not Provided
Not Provided
Bowel Preparation Before Rectal Cancer Surgery
Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery

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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Rectal Cancer
  • Dietary Supplement: Fresubin Energy Drink
    Fresubin energy drink 30 kcal/kg*dag-1, seven days before surgery
  • Drug: Laxabon®
    Laxabon® 4 litres starting the day before surgery
  • B
    Nutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon®
    Intervention: Dietary Supplement: Fresubin Energy Drink
  • A
    Traditional bowel preparation with Laxabon®
    Intervention: Drug: Laxabon®
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • rectal cancer
  • men
  • women
  • age 18-90 years

Exclusion Criteria:

  • acute ileus
  • seriously dementia
  • metastatic disease
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Ulf Gustafsson, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Ulf Gustafsson, MD, PhD Karolinska Institut
Karolinska Institutet
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP