Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid. (REPREP1)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Sponsor:
Information provided by (Responsible Party):
Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT02073552
First received: February 25, 2014
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation


Condition Intervention Phase
Colonoscopy Preparation
Drug: Polyethylene glycol 4000
Drug: Macrogol 3350 plus ascorbic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Randomized Clinical Trial to Evaluate the Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid in Patients With Past Poor Colonic Preparation

Resource links provided by NLM:


Further study details as provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:

Primary Outcome Measures:
  • Colon cleansing [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Colon cleansing will be assessed just after colonoscopy by the endoscopist in charge of performing the examination and afterwards images were reviewed by a the staff of endoscopists for validation (30 days). For assessing colon cleansing a validated scale (Boston scale) will be used.


Secondary Outcome Measures:
  • Tolerance of bowel preparation [ Time Frame: Tolerance will be assessed just before colonoscopy by a research assistant ] [ Designated as safety issue: No ]
    It will be assessed by using a visual analog scale colon

  • Detection of colorectal neoplasia [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Detection rate of adenoma and colorectal cancer will be assessed for both groups (low volume and high volume preparation)


Estimated Enrollment: 438
Study Start Date: April 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High volume
  • Two 5 mg bisacodyl tablets It is a stimulant laxative with local action.
  • Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate.
Drug: Polyethylene glycol 4000
- Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate. These substances make PEG metabolically inert, achieving a suitable osmotic balance, despite having a high molecular weight. The preparation passes along the gastrointestinal tract without causing net absorption of fluid or electrolytes. It is routinely used in clinical practice for bowel cleansing, before abdominal surgery, barium enema and other colorectal and genitourinary tract tests. Participants will divide the whole doses in 4 liters of water taking half the day before the examination starting at 20.00 h and the other half at 6.00 pm on the day of the examination.
Experimental: Low volume
  • Two 5 mg bisacodyl tablets, taken in the same way as for the high volume group.
  • Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid.
Drug: Macrogol 3350 plus ascorbic acid
- Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid. The properties of the polyethylene glycol are the same as those mentioned previously, while ascorbic acid generates an osmotic gradient potentiating the effect of polyethylene glycol. It is used routinely as a bowel prep. Participants will divide the doses in 2 liters of water taking half the day before (112 g of PEG and an 11 g of ascorbic acid) the examination at 20.00 h and the other half at 6.00 pm on the day of the examination

Detailed Description:

Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing. Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of colonoscopy.

The most important factor associated with poor colonic preparation is the past history of poor bowel preparation. However, there are no recommendations on the proper type of preparation in those patients. In two non-randomized studies inadequate cleansing in the second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4 liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients, are therefore needed before making any recommendations in this regard.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> 18 years
  • Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5.
  • Signed informed consent

Exclusion Criteria:

paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia.

  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: NCT02073552

Contacts
Contact: Antonio Z. Gimeno García, MD, PhD 34922678554 ext 34554 antozeben@gmail.com
Contact: Enrique Quintero, MD,PhD 34922678554 ext 34554 equinter@gmail.com

Locations
Spain
Hospital Universitario de Canarias Not yet recruiting
Santa Cruz de Tenerife, Spain, 38320
Contact: Antonio Z Gimeno Garcia, MD, PhD    34922678554 ext 34554    antozeben@gmail.com   
Contact: Enrique Quinero Carrión, MD, PhD    34922678554 ext 34554    equinter@gmail.com   
Principal Investigator: Antonio Z Gimeno García, MD, PhD         
Sub-Investigator: David Nicolás Pérez, MD, PhD         
Sub-Investigator: Zaida Adrián de Ganzo, MD         
Sub-Investigator: Enrique Quintero Carrión, MD, PhD         
Sub-Investigator: Onofre Alarcón Fernández, MD         
Sub-Investigator: Ana Aldea Perona, MD         
Sponsors and Collaborators
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Investigators
Principal Investigator: Antonio Z Gimeno García, MD, PhD Hospital Universitario de Canarias
  More Information

Publications:

Responsible Party: Enrique Quintero, MD,PhD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier: NCT02073552     History of Changes
Other Study ID Numbers: REPREP1, 2013-002506-31
Study First Received: February 25, 2014
Last Updated: February 27, 2014
Health Authority: Spain: Spanish Agency of Medicines
European Union: European Medicines Agency

Keywords provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:
colon cleansing, bowel preparations; polyethyleneglycol

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

ClinicalTrials.gov processed this record on August 19, 2014