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Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT01853709
Recruitment Status : Unknown
Verified May 2013 by Felix Junquera, Corporacion Parc Tauli.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Felix Junquera, Corporacion Parc Tauli

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.


Condition or disease Intervention/treatment Phase
Bowel Preparation for Colonoscopy Behavioral: Education Other: Fiber free diet Dietary Supplement: Adjuvants Drug: Polyethylene glycol (PEG) Drug: Bisacodyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
Study Start Date : May 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: 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

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

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of patients with adequate bowel preparation by bowel segments [ Time Frame: At the time of performing the colonoscopy ]
    The boston scale will be assessed by the investigators during the procedure.

  2. Tolerance to the colonoscopy [ Time Frame: from colonoscopy up to 24 hours after colonoscopy ]
    Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy

  3. Percentage of complete/incomplete colonoscopies and reprogramming [ Time Frame: After the colonoscopy ]
    Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy

  4. Complications during and after the procedure [ Time Frame: up to 24 hours after colonoscopy ]
  5. Doses of sedation needed during the colonoscopy [ Time Frame: During the colonoscopy process ]
    Final dose will be calculated at the end of the procedure

  6. Tolerance to the preparation [ Time Frame: up to 48 hours ]
  7. Endoscopic findings [ Time Frame: during the colonoscopy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853709


Contacts
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Contact: Félix Junquera, PhD 34937458320 fjunquera@tauli.cat

Locations
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Spain
Hospital de Sabadell Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Principal Investigator: Felix Junquera         
Sponsors and Collaborators
Corporacion Parc Tauli

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Responsible Party: Felix Junquera, Consultant Physician - Gastroenterology, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01853709     History of Changes
Other Study ID Numbers: CSPT-END-DIG-2012
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives