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

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.

Study Overview

• Status: Unknown
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Behavioral: Education; Other: Fiber free diet; Dietary supplement: Adjuvants; Drug: Polyethylene glycol (PEG); Drug: Bisacodyl

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Félix Junquera, PhD; Phone Number: 34937458320; Email: fjunquera@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital de Sabadell
      • Principal Investigator: Felix Junquera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients with adequate bowel preparation	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)	at the time of performing the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with adequate bowel preparation by bowel segments	The boston scale will be assessed by the investigators during the procedure.	At the time of performing the colonoscopy
Tolerance to the colonoscopy	Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy	from colonoscopy up to 24 hours after colonoscopy
Percentage of complete/incomplete colonoscopies and reprogramming	Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy	After the colonoscopy
Complications during and after the procedure		up to 24 hours after colonoscopy
Doses of sedation needed during the colonoscopy	Final dose will be calculated at the end of the procedure	During the colonoscopy process
Tolerance to the preparation		up to 48 hours
Endoscopic findings		during the colonoscopy

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: CSPT-END-DIG-2012