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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Dietary Supplement: Fresubin Energy Drink Drug: Laxabon® Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery
Study Start Date : July 2008
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Nutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon®
Dietary Supplement: Fresubin Energy Drink
Fresubin energy drink 30 kcal/kg*dag-1, seven days before surgery

Traditional bowel preparation with Laxabon®
Drug: Laxabon®
Laxabon® 4 litres starting the day before surgery

Primary Outcome Measures :
  1. Bowel purity degree [ Time Frame: day of surgery ]

Secondary Outcome Measures :
  1. Nutritional status [ Time Frame: before and after operation ]
  2. Complications [ Time Frame: day of surgery and days after surgery ]
  3. physiological function [ Time Frame: before and after surgery ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • acute ileus
  • seriously dementia
  • metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687570

Research Department, Ersta Hospital
Stockholm, Sweden, SE116 91
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Ulf Gustafsson, MD, PhD Karolinska Institut

Responsible Party: Ulf Gustafsson, PhD, MD, Karolinska Institutet Identifier: NCT00687570     History of Changes
Other Study ID Numbers: 2008/332-31
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015

Keywords provided by Ulf Gustafsson, Karolinska Institutet:
patients with rectal cancer undergoing surgery
Bowel purity degree
Bowel preparation
Rectal cancer
Nutritional status
complications with traditional bowel preparation
Physiological status

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases