Bowel Preparation Before Colonoscopy
|ClinicalTrials.gov Identifier: NCT00675324|
Recruitment Status : Terminated (The bowel was not clean when the colonoscopy was performed)
First Posted : May 9, 2008
Last Update Posted : September 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy Bowel Preparation||Drug: Laxabon Dietary Supplement: Fresubin Energy drink||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: A
Traditional bowel preparation with 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
- Bowel purity degree [ Time Frame: day of coclonscopy ]
- Reduction of complications for patients with cardio- vascular and kidney diseases [ Time Frame: day of cocloscopy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675324
|Stockholm, Stockholm county, Sweden, SE-116 91|
|Principal Investigator:||Ulf Gustafsson, PhD, MD||Karolinska Institutet|