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.

Study Overview

• Status: Terminated
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: Laxabon; Dietary supplement: Fresubin Energy drink

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm county
    • Stockholm, Stockholm county, Sweden, SE-116 91
      • Ersta Hospital,

Participation Criteria

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:

• men
• women
• age 18-90 years

Exclusion Criteria:

• patients under 18 years
• acute colitis
• acute ileus
• seriously dementia
• patients from other counties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bowel purity degree	day of coclonscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of complications for patients with cardio- vascular and kidney diseases	day of cocloscopy

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm; Research department, Ersta Hospital
• Investigators: Principal Investigator: Ulf Gustafsson, PhD, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: May 7, 2008
• First Submitted That Met QC Criteria: May 8, 2008
• First Posted (Estimate): May 9, 2008

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Colonoscopy; Bowel preparation; Salt and electrolyte balance; Patients undergoing colonoscopy; Complication with traditional bowel preparation; Bowel purity degree without traditional bowel preparation
• Other Study ID Numbers: 2008/104-31/3