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UnknownNCT01853709

Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
162 (estimated)
Sponsor
Corporacion Parc Tauli · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALEducation
OTHERFiber free diet
DIETARY_SUPPLEMENTAdjuvants
DRUGPolyethylene glycol (PEG)
DRUGBisacodyl

Timeline

Start date
2013-05-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2013-05-15
Last updated
2013-05-15

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01853709. Inclusion in this directory is not an endorsement.