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Completed

NCT Number: NCT01685853

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

European Institute of Oncology

Milan, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisacodyl plus PEG-CS

Drug
  • 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 names: LOVOLdyl plus LOVOLesse

PEG 4 litres split

Drug
  • the day before colonoscopy: 2 litres of PEG
  • the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination

Other names: SELG 1000

Primary outcomes

  1. Efficacy

    Time frame: 20 min

    Evaluation of the quality of bowel preparation according to the Ottawa Scale

Secondary outcomes

  1. Efficacy

    Time frame: 20 min

    Evaluation of the mucosal visibility according to a 3 point scale (0-2)

  2. Efficacy

    Time frame: 20 min

    Adenoma detection rate

  3. Safety

    Time frame: 24 hours

    Recording of all adverse events occurred during the study by patient questioning

  4. Tolerability

    Time frame: 24 hours

    rate of patients in the two groups who developed GI symptoms related to bowel preparation

  5. Acceptability

    Time frame: 24 hours

    willingness to repeat the preparation

  6. Compliance

    Time frame: 24 hours

    rate of patient with intake of at least 75% of bowel preparation

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2012
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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