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| Sponsors and Collaborators: |
Karolinska Institutet Stockholm County Council Research department, Ersta Hospital |
|---|---|
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00675324 |
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: | Basic Science, Randomized, Single Blind (Caregiver), Parallel Assignment |
| Official Title: | Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation |
| Estimated Enrollment: | 140 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Traditional bowel preparation with Laxabon
|
Drug: Laxabon
Laxabon 4 litres, starting the day (e.m.) before the colonoscopy
|
|
B: Active Comparator
Bowel preparation with nutritional drinks
|
Dietary Supplement: Fresubin Energy drink
30 kcal/kg*day five days before colonoscopy
|
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ulf Gustafsson, MD, PhD-stud | 46-8-714-6582 ext 6582 | Ulf.Gustafsson@erstadiakoni.se |
| Contact: Jonas Nygren, MD, PhD | 46-8-714-6542 ext 6542 | Jonas.Nygren@erstadiakoni.se |
| Sweden, Stockholm county | |
| Ersta Hospital, | Recruiting |
| Stockholm, Stockholm county, Sweden, SE-116 91 | |
| Contact: Ulf Gustafsson, MD, PhD-stud 46-8-714-6582 ext 6582 Ulf.Gustafsson@erstadiakoni.se | |
| Contact: Jonas Nygren, MD, PhD 46-8-714-6542 ext 6542 Jonas.Nygren@erstadiakoni.se | |
| Sub-Investigator: Ulf Gustafsson, MD, PhD stud | |
| Sub-Investigator: Jonas Nygren, MD, PhD | |
| Principal Investigator: Anders Thorell, MD, PhD | |
| Principal Investigator: | Anders Thorell, MD, PhD | Karolinska Institutet, Ersta Hospital |
More Information
| Responsible Party: | Karolinska Institutet, Ersta Sjukhus ( Anders Thorell ) |
| Study ID Numbers: | 2008/104-31/3 |
| Study First Received: | May 7, 2008 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00675324 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
|
Colonoscopy Bowel preparation Salt and electrolyte balance |
Patients undergoing colonoscopy Complication with traditional bowel preparation Bowel purity degree without traditional bowel preparation |
