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Bowel Preparation Before Colonoscopy

This study has been terminated.
(The bowel was not clean when the colonoscopy was performed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675324
First Posted: May 9, 2008
Last Update Posted: September 18, 2012
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.
Collaborators:
Stockholm County Council, Sweden
Research department, Ersta Hospital
Information provided by (Responsible Party):
Ulf Gustafsson, Karolinska Institutet
  Purpose
Bowel preparation can be a troublesome procedure for patients undergoing colonoscopy. For patients with cardio-vascular and kidney disorders it may be dangerous with traditional bowel preparation with regard to salt and electrolyte balance. This study's purpose is to find out if nutritional drinks can replace traditional bowel preparation before colonoscopy in regard to Bowel purity degree, disturbances in the salt and electrolyte balance in the nutritional group versus the group that gets traditional bowel preparation. And if the patients tolerate nutritional drinks better than traditional bowel preparation.

Condition Intervention
Colonoscopy Bowel Preparation Drug: Laxabon Dietary Supplement: Fresubin Energy drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Basic Science
Official Title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation

Resource links provided by NLM:


Further study details as provided by Ulf Gustafsson, Karolinska Institutet:

Primary Outcome Measures:
  • Bowel purity degree [ Time Frame: day of coclonscopy ]

Secondary Outcome Measures:
  • Reduction of complications for patients with cardio- vascular and kidney diseases [ Time Frame: day of cocloscopy ]

Enrollment: 47
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Traditional bowel preparation with Laxabon
Drug: Laxabon
Laxabon 4 litres, starting the day (e.m.) before the colonoscopy
Active Comparator: B
Bowel preparation with nutritional drinks
Dietary Supplement: Fresubin Energy drink
30 kcal/kg*day five days before colonoscopy

Detailed Description:

Today colonoscopy is a standard method for examination of the colon. To correctly diagnose and give adequate therapy after colonoscopy examination it is necessary with a thoroughly done bowel preparation, i.e. the intestines should preferably be empty. The ideal preparation should not only be reliable and easy to carry out but also be done without discomfort for the patient. Unfortunately we do not today have any purgative that fulfils these criteria's.

Studies have shown that Phosforal compared to Laxabon have the same or even a better effect regarding the bowel preparation and also a higher patient tolerance. The amount of side effects with Phosforal is larger and has potentially greater medical effects for the patient. Phosforal might result in serious changes in the liquid- and salt-balance and especially patients with heart diseases and kidney dysfunctions should be restricted to use this preparation.

Laxabon, on the other hand, has not showed any side effects for changes in the salt balance, but studies have shown that up to 40% of the patients are not able to drink such a large amount as four litres. Side effects as nausea, vomiting and discomfort are common.

At Ersta hospital we have for many years done research studies on the metabolic response in connection with surgery. Patients undergoing surgery for cancer in the rectum often are 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. 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. We have also prepared some patient for colonoscopy, that due to their primary disease not are able to use traditional purgatives, with nutritional drinks for five days combined with a local purgative on the day of the examination. The colonoscopy examination on these patients were performed without any problems. We have found no studies describing this preparation before colonoscopy.

This is a study that will find out if traditional preparation before colonoscopy could be replaced by nutritional drinks combined with local purgative on the day of the examination.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • men
  • women
  • age 18-90 years

Exclusion Criteria:

  • patients under 18 years
  • acute colitis
  • acute ileus
  • seriously dementia
  • patients from other counties
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00675324


Locations
Sweden
Ersta Hospital,
Stockholm, Stockholm county, Sweden, SE-116 91
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Research department, Ersta Hospital
Investigators
Principal Investigator: Ulf Gustafsson, PhD, MD Karolinska Institutet
  More Information

Responsible Party: Ulf Gustafsson, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00675324     History of Changes
Other Study ID Numbers: 2008/104-31/3
First Submitted: May 7, 2008
First Posted: May 9, 2008
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Ulf Gustafsson, Karolinska Institutet:
Colonoscopy
Bowel preparation
Salt and electrolyte balance
Patients undergoing colonoscopy
Complication with traditional bowel preparation
Bowel purity degree without traditional bowel preparation