Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01685853
First received: September 12, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.


Condition Intervention Phase
Colonoscopy
Drug: Bisacodyl plus PEG-CS
Drug: PEG 4 litres split
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 20 min ] [ Designated as safety issue: No ]
    Evaluation of the quality of bowel preparation according to the Ottawa Scale


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 20 min ] [ Designated as safety issue: No ]
    Evaluation of the mucosal visibility according to a 3 point scale (0-2)

  • Efficacy [ Time Frame: 20 min ] [ Designated as safety issue: No ]
    Adenoma detection rate

  • Safety [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Recording of all adverse events occurred during the study by patient questioning

  • Tolerability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    rate of patients in the two groups who developed GI symptoms related to bowel preparation

  • Acceptability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    willingness to repeat the preparation

  • Compliance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    rate of patient with intake of at least 75% of bowel preparation


Enrollment: 164
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG 4 litres split
Polyethylene glycol with electrolytes (PEG)
Drug: PEG 4 litres split
  • the day before colonoscopy: 2 litres of PEG
  • the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
Other Name: SELG 1000
Experimental: Bisacodyl plus PEG-CS
Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)
Drug: Bisacodyl plus PEG-CS
  • the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime
  • the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam
Other Name: LOVOLdyl plus LOVOLesse

Detailed Description:

Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-patients undergoing a complete colonoscopy
  • Patient written informed consent

Exclusion Criteria:

  • Pregnant or lactating women or at a risk of becoming pregnant
  • Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685853

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Cristiano Crosta, MD European Institute of Oncology
  More Information

No publications provided

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT01685853     History of Changes
Other Study ID Numbers: IEO S570 510, 2010-022967-37
Study First Received: September 12, 2012
Last Updated: September 18, 2012
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014