Bowel Preparation Before Colonoscopy

NCT ID: NCT00675324

Last Updated: 2012-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-10-31

Brief Summary

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.

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.

Conditions

Colonoscopy; Bowel Preparation

Keywords

Colonoscopy; Bowel preparation; Salt and electrolyte balance; Patients undergoing colonoscopy; Complication with traditional bowel preparation; Bowel purity degree without traditional bowel preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

A

Traditional bowel preparation with Laxabon

Group Type: ACTIVE_COMPARATOR

Laxabon

Intervention Type: DRUG

Laxabon 4 litres, starting the day (e.m.) before the colonoscopy

B

Bowel preparation with nutritional drinks

Group Type: ACTIVE_COMPARATOR

Fresubin Energy drink

Intervention Type: DIETARY_SUPPLEMENT

30 kcal/kg\*day five days before colonoscopy

Interventions

Laxabon

Laxabon 4 litres, starting the day (e.m.) before the colonoscopy

Intervention Type: DRUG

Fresubin Energy drink

30 kcal/kg\*day five days before colonoscopy

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Research department, Ersta Hospital

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Ulf Gustafsson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Gustafsson, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Ersta Hospital,

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

2008/104-31/3

Identifier Type: -

Identifier Source: org_study_id