Bowel Preparation Before Rectal Cancer Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ulf Gustafsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00687570
First received: May 28, 2008
Last updated: August 20, 2013
Last verified: August 2013

May 28, 2008
August 20, 2013
July 2008
January 2014   (final data collection date for primary outcome measure)
Bowel purity degree [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687570 on ClinicalTrials.gov Archive Site
  • Nutritional status [ Time Frame: before and after operation ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: day of surgery and days after surgery ] [ Designated as safety issue: Yes ]
  • physiological function [ Time Frame: before and after surgery ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
January 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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00687570
2008/332-31
No
Ulf Gustafsson, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Ulf Gustafsson, MD, PhD Karolinska Institut
Karolinska Institutet
August 2013

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