Bowel Preparation Before Rectal Cancer Surgery

February 19, 2015 updated by: Ulf Gustafsson, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE116 91
        • Research Department, Ersta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • acute ileus
  • seriously dementia
  • metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: A
Traditional bowel preparation with Laxabon®
Drug: Laxabon®
Laxabon® 4 litres starting the day before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bowel purity degree
Time Frame: day of surgery
day of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Nutritional status
Time Frame: before and after operation
before and after operation
Complications
Time Frame: day of surgery and days after surgery
day of surgery and days after surgery
physiological function
Time Frame: before and after surgery
before and after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Ulf Gustafsson, MD, PhD, Karolinska Institut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (ESTIMATE)

June 2, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/332-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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