Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bowel Preparation Before Colonoscopy

This study has been terminated.
(The bowel was not clean when the colonoscopy was performed)
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Research department, Ersta Hospital
Information provided by (Responsible Party):
Ulf Gustafsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00675324
First received: May 7, 2008
Last updated: September 17, 2012
Last verified: September 2012

May 7, 2008
September 17, 2012
April 2008
October 2009   (final data collection date for primary outcome measure)
Bowel purity degree [ Time Frame: day of coclonscopy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675324 on ClinicalTrials.gov Archive Site
Reduction of complications for patients with cardio- vascular and kidney diseases [ Time Frame: day of cocloscopy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bowel Preparation Before Colonoscopy
Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Basic Science
  • Colonoscopy
  • Bowel Preparation
  • Drug: Laxabon
    Laxabon 4 litres, starting the day (e.m.) before the colonoscopy
  • Dietary Supplement: Fresubin Energy drink
    30 kcal/kg*day five days before colonoscopy
  • Active Comparator: A
    Traditional bowel preparation with Laxabon
    Intervention: Drug: Laxabon
  • Active Comparator: B
    Bowel preparation with nutritional drinks
    Intervention: Dietary Supplement: Fresubin Energy drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men
  • women
  • age 18-90 years

Exclusion Criteria:

  • patients under 18 years
  • acute colitis
  • acute ileus
  • seriously dementia
  • patients from other counties
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00675324
2008/104-31/3
No
Ulf Gustafsson, Karolinska Institutet
Karolinska Institutet
  • Stockholm County Council, Sweden
  • Research department, Ersta Hospital
Principal Investigator: Ulf Gustafsson, PhD, MD Karolinska Institutet
Karolinska Institutet
September 2012

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