Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

NCT ID: NCT01853709

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

Brief Summary

Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.

The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.

Conditions

Bowel Preparation for Colonoscopy

Study Design

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

Study Groups

Multidisciplinary approach

The multidisciplinary approach will include:

Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Fiber free diet

Intervention Type: OTHER

Adjuvants

Intervention Type: DIETARY_SUPPLEMENT

Polyethylene glycol (PEG)

Intervention Type: DRUG

Bisacodyl

Intervention Type: DRUG

Conventional approach

The conventional approach will include:

Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

Fiber free diet

Intervention Type: OTHER

Polyethylene glycol (PEG)

Intervention Type: DRUG

Interventions

Education

Intervention Type: BEHAVIORAL

Fiber free diet

Intervention Type: OTHER

Adjuvants

Intervention Type: DIETARY_SUPPLEMENT

Polyethylene glycol (PEG)

Intervention Type: DRUG

Bisacodyl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hospitalized patients who undergo a non urgent colonoscopy
• Patients who give informed consent to participate in the study
• Patients older than 18 years
• Patients who undergo total colonoscopy

Exclusion Criteria

• Non compliance with the 48 hours diet prescribed
• The endoscopy planned is a rectosigmoidoscopy
• Previous colonic surgery
• Mental/cognitive impairment preventing the study assessments
• Severe renal failure
• Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia)
• Intestinal obstruction, perforation or toxic megacolon
• Pregnant or nursing women
• Allergy/intolerance to PEG, bisacodyl or adjuvants
• No informed consent

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

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Felix Junquera

Consultant Physician - Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

Central Contacts

Félix Junquera, PhD

Role: CONTACT

fjunquera@tauli.cat

34937458320

Other Identifiers

CSPT-END-DIG-2012

Identifier Type: -

Identifier Source: org_study_id