Clinical trial NCT01853709: Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients
Official title: Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation for Colonoscopy
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: percentage of patients with adequate bowel preparation
timeFrame: at the time of performing the colonoscopy
Secondary outcomes:
measure: Percentage of patients with adequate bowel preparation by bowel segments
timeFrame: At the time of performing the colonoscopy
measure: Tolerance to the colonoscopy
timeFrame: from colonoscopy up to 24 hours after colonoscopy
measure: Percentage of complete/incomplete colonoscopies and reprogramming
timeFrame: After the colonoscopy
measure: Complications during and after the procedure
timeFrame: up to 24 hours after colonoscopy
measure: Doses of sedation needed during the colonoscopy
timeFrame: During the colonoscopy process
measure: Tolerance to the preparation
timeFrame: up to 48 hours
measure: Endoscopic findings
timeFrame: during the colonoscopy
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
Study officials:
References: