Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • 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.
  • 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
  • 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
  • Complications during and after the procedure [ Time Frame: up to 24 hours after colonoscopy ]
  • Doses of sedation needed during the colonoscopy [ Time Frame: During the colonoscopy process ]
    Final dose will be calculated at the end of the procedure
  • Tolerance to the preparation [ Time Frame: up to 48 hours ]
  • Endoscopic findings [ Time Frame: during the colonoscopy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients
Official Title  ICMJE Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bowel Preparation for Colonoscopy
Intervention  ICMJE
  • Behavioral: Education
  • Other: Fiber free diet
  • Dietary Supplement: Adjuvants
  • Drug: Polyethylene glycol (PEG)
  • Drug: Bisacodyl
Study Arms  ICMJE
  • 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

    Interventions:
    • 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

    Interventions:
    • Behavioral: Education
    • Other: Fiber free diet
    • Drug: Polyethylene glycol (PEG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2013)
162
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01853709
Other Study ID Numbers  ICMJE CSPT-END-DIG-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felix Junquera, Corporacion Parc Tauli
Study Sponsor  ICMJE Corporacion Parc Tauli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Corporacion Parc Tauli
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP