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Clinical Trials/NCT01853709
NCT01853709
Unknown
Phase 4

Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial

Corporacion Parc Tauli1 site in 1 country162 target enrollmentMay 2013

Overview

Phase
Phase 4
Intervention
Polyethylene glycol (PEG)
Conditions
Bowel Preparation for Colonoscopy
Sponsor
Corporacion Parc Tauli
Enrollment
162
Locations
1
Primary Endpoint
percentage of patients with adequate bowel preparation
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Felix Junquera

Consultant Physician - Gastroenterology

Corporacion Parc Tauli

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

Arms & Interventions

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

Intervention: Polyethylene glycol (PEG)

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

Intervention: Education

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

Intervention: Fiber free diet

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

Intervention: Adjuvants

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

Intervention: Polyethylene glycol (PEG)

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

Intervention: Bisacodyl

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

Intervention: Education

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

Intervention: Fiber free diet

Outcomes

Primary Outcomes

percentage of patients with adequate bowel preparation

Time Frame: at the time of performing the colonoscopy

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)

Secondary Outcomes

  • 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)
  • Tolerance to the preparation(up to 48 hours)
  • Endoscopic findings(during the colonoscopy)

Study Sites (1)

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