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Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice (REPREP2)

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ClinicalTrials.gov Identifier: NCT03830489
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Brief Summary:

This is a single center randomized controlled trial to compare the colon cleansing quality determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with high risk of poor colon cleansing defined as those patients with a score> 1.225 following a predictive score previously published: one group will receive an intensified split-dose 4 L polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.

Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.


Condition or disease Intervention/treatment Phase
Cleansing Quality of the Colon Drug: polyethylene glycol Drug: polyethylene glycol plus ascorbic acid Phase 4

Detailed Description:

This is a prospective, randomized, single-blind phase IV study in which all outpatients scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional or intensified) according to a scoring system already validated in the investigator's center, designed with variables independently associated with poor bowel cleansing, constipation, abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to this system, a score equal to or less than 1.225, predicts with a high confidence (negative predictive value = 88%) a suitable cleansing quality with a standard preparation protocol. Therefore, these subjects will be advised of a conventional preparation (low fiber diet the day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a control is supported by the absence of significant differences in quality of cleanliness in patients with a score > 1.225 among patients prepared with high or low volume and that low volume preparation appears to improve tolerance and compliance.

A researcher will offer to participate in the study to all outpatients with a scheduled colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the bowel preparation strategy. Thus, according to the allocation group, participants must comply with a large volume cleansing strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional preparation will be recommended.

Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.

The hypothesis of the study is that in patients with a high risk of poor bowel preparation, the large bowel based preparation strategy is superior to the conventional bowel preparation in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Only the endoscopists in charge of rating the bowel cleansing during the colonoscopy will be masked
Primary Purpose: Other
Official Title: Intensive High-volume Bowel Cleansing Regimen Versus Low-volume Bowel Regimen in Patients With a High Risk of Poor Colonic Cleansing Following a Validated Predictive Score
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Large volume based preparation
This strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet.
Drug: polyethylene glycol
The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet

Active Comparator: Low volume based preparation
This strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet
Drug: polyethylene glycol plus ascorbic acid
The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet




Primary Outcome Measures :
  1. Boston Bowel Preparation Scale [ Time Frame: 8 months ]
    This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points


Secondary Outcome Measures :
  1. Proportion of polyps detected in each arm [ Time Frame: 8 months ]
    Number of polyps in one arm/total of polyps detected

  2. Tolerance to bowel preparation [ Time Frame: 8 months ]
    It will be subjective and assessed by a visual analog scale (0 very bad, 10 excellent)



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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:

  • Age ≥ 18 years
  • Outpatient colonoscopy
  • Willing to participate (informed consent signed).

Exclusion Criteria:

  • Intestinal perforation
  • Poorly controlled arterial hypertension (HTAS> 180 HTAD> 100)
  • Congestive heart failure
  • NYHA III-IV
  • Acute hepatic failure
  • End-stage renal disease (creatinine <15 ml / min dialysis or pre-dialysis)
  • Pregnancy or breastfeeding
  • Known hypersensitivity reaction to drug components
  • Phenylketonuria or Glucose-6-phosphate dehydrogenase deficiency
  • Dementia with difficulty in intake of Preparation
  • Past history of poor bowel preparation colonic cleanliness
  • Inability to follow the instructions

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): NCT03830489


Contacts
Contact: Antonio Z Gimeno Garcia, MD, PhD 34922678039 antozeben@gmail.com

Locations
Spain
Department of Gastroenterology Not yet recruiting
La Laguna, S/C De Tenerife, Spain, 38320
Contact: Antonio Z Gimeno Garcia, MD, hD    34922678039    antozeben@gmail.com   
Sub-Investigator: Ana Aldea, MD, PhD         
Sub-Investigator: David Nicolas Perez, MD, PhD         
Sub-Investigator: Enrique Quintero, MD, PhD         
Principal Investigator: Goretti Hernandez Mesa, MD         
Principal Investigator: Antonio Z Gimeno Garcia, MD, PhD         
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Goretti Hernandez, MD Hospital Universitario de Canarias

Publications of Results:

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT03830489     History of Changes
Other Study ID Numbers: Score-guided colon cleansing
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hospital Universitario de Canarias:
Cleansing quality score
Colonoscopy

Additional relevant MeSH terms:
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances