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
  Purpose

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 Intervention
Rectal Cancer
Dietary Supplement: Fresubin Energy Drink
Drug: Laxabon®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Bowel purity degree [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
B
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
A
Traditional bowel preparation with Laxabon®
Drug: Laxabon®
Laxabon® 4 litres starting the day before surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute ileus
  • seriously dementia
  • metastatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687570

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

No publications provided

Responsible Party: Ulf Gustafsson, PhD, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00687570     History of Changes
Other Study ID Numbers: 2008/332-31
Study First Received: May 28, 2008
Last Updated: August 20, 2013
Health Authority: Sweden: The National Board of Health and Welfare

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

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

ClinicalTrials.gov processed this record on July 22, 2014