Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

NCT01853709 | Unknown Phase 4

• 1 other identifier: CSPT-END-DIG-2012
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• percentage of patients with adequate bowel preparation

  Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)

  at the time of performing the colonoscopy

Secondary Outcomes (7)

• Percentage of patients with adequate bowel preparation by bowel segments

  At the time of performing the colonoscopy

• Tolerance to the colonoscopy

  from colonoscopy up to 24 hours after colonoscopy

• Percentage of complete/incomplete colonoscopies and reprogramming

  After the colonoscopy

• Complications during and after the procedure

  up to 24 hours after colonoscopy

• Doses of sedation needed during the colonoscopy

  During the colonoscopy process

Study Arms (2)

Multidisciplinary approach

EXPERIMENTAL

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

Behavioral: Education; Other: Fiber free diet; Dietary Supplement: Adjuvants; Drug: Polyethylene glycol (PEG); Drug: Bisacodyl

Conventional approach

ACTIVE COMPARATOR

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

Behavioral: Education; Other: Fiber free diet; Drug: Polyethylene glycol (PEG)

Interventions

Education BEHAVIORAL

Conventional approach; Multidisciplinary approach

Fiber free diet OTHER

Conventional approach; Multidisciplinary approach

Adjuvants DIETARY_SUPPLEMENT

Multidisciplinary approach

Polyethylene glycol (PEG) DRUG

Conventional approach; Multidisciplinary approach

Bisacodyl DRUG

Multidisciplinary approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Interventions

Educational Status; Polyethylene Glycols; Bisacodyl

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Félix Junquera, PhD

CONTACT

34937458320; fjunquera@tauli.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician - Gastroenterology

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 15, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

ES (1)