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Completed

NCT Number: NCT02297399

Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

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

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Key information

Conditions

Diabetes Mellitus Behavior Colonic Diseases Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Intestinal Diseases Metabolic Diseases Nutritional and Metabolic Diseases Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PEG-ascorbate 2L

Drug

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®

PEG 4L

Drug

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®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Adverse events

    Time frame: 30 days after the colonoscopy

    Description of any adverse event occurred during the study period

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Germans Trias i Pujol Hospital

Registry information

Official study title

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.

Acronym: iDIMEPREP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2014
Registry last updated
Feb 23, 2017

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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