Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients (iDIMEPREP)

February 21, 2017 updated by: Marco Antonio Alvarez Gonzalez, Parc de Salut Mar

Improvement of Tolerability for Bowel Preparation for Colonoscopy in Diabetic Patients. A Randomized Controlled Trial of Two Bowel Preparation Protocols Including 4 Liters PEG vs. 2 Liters PEG Plus Ascorbic Acid. iDIMEPREP Study.

This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure.

Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case.

Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
  • Diabetes mellitus (being treated with insulin or any oral agent).

Exclusion Criteria:

  • Unwillingness to participate.
  • Hospital admission at the time of colonoscopy.
  • Inability to follow instructions
  • Active inflammatory bowel disease
  • Previous colectomy.
  • Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEG-ascorbate 2L
Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
Drug: PEG-ascorbate 2L

Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.

Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.

Other Names:
  • Moviprep®
Active Comparator: PEG 4L
Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
Drug: PEG 4L

Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.

Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.

Other Names:
  • Bohm®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of the bowel preparation (analogue visual scale)
Time Frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale.
6 hours after finishing bowel preparation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the planned bowel cleansing method (questionnaire)
Time Frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in a questionnaire.
6 hours after finishing bowel preparation
Ease of consumption and taste of the laxative (analogue visual scale)
Time Frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale.
6 hours after finishing bowel preparation
Abdominal pain, nausea and bloating (analogue visual scale)
Time Frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale.
6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
Time Frame: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in a questionnaire.
6 hours after finishing bowel preparation
Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
Time Frame: 10 minutes after the colonoscopy
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
10 minutes after the colonoscopy
Adverse events
Time Frame: 30 days after the colonoscopy
Description of any adverse event occurred during the study period
30 days after the colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Marco Antonio Alvarez González, MD, PhD, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Actual)

January 26, 2016

Study Completion (Actual)

January 26, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4790-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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