Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

Corporacion Parc Tauli

Status and phase: Unknown; Phase 4

Conditions: Bowel Preparation for Colonoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01853709

CSPT-END-DIG-2012

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups

Multidisciplinary approach

Experimental group

Description:

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

Treatment:

Drug: Bisacodyl

Drug: Polyethylene glycol (PEG)

Dietary Supplement: Adjuvants

Other: Fiber free diet

Behavioral: Education

Conventional approach

Active Comparator group

Description:

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

Treatment:

Drug: Polyethylene glycol (PEG)

Other: Fiber free diet

Behavioral: Education