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


N/A
18 Years
90 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- rectal cancer

- men

- women

- age 18-90 years

Exclusion Criteria:

- acute ileus

- seriously dementia

- metastatic disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Bowel purity degree

Outcome Time Frame:

day of surgery

Safety Issue:

No

Principal Investigator

Ulf Gustafsson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institut

Authority:

Sweden: The National Board of Health and Welfare

Study ID:

2008/332-31

NCT ID:

NCT00687570

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Rectal Cancer
  • patients with rectal cancer undergoing surgery
  • Bowel purity degree
  • Bowel preparation
  • Rectal cancer
  • Nutritional status
  • complications with traditional bowel preparation
  • Complications
  • Physiological status
  • Rectal Neoplasms

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