Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, colonic diseases
Treatments peg-ascorbate 2l, peg 4l
Phase phase 3
Sponsor Parc de Salut Mar
Collaborator Germans Trias i Pujol Hospital
Start date December 2014
End date March 2015
Trial size 160 participants
Trial identifier NCT02297399, 4790-I

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose supportive care
Arm
(Experimental)
Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
peg-ascorbate 2l Moviprep®
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.
(Active Comparator)
Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
peg 4l Bohm®
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.

Primary Outcomes

Measure
Tolerability of the bowel preparation (analogue visual scale)
time frame: 6 hours after finishing bowel preparation

Secondary Outcomes

Measure
Ease of consumption and taste of the laxative (analogue visual scale)
time frame: 6 hours after finishing bowel preparation
Abdominal pain, nausea and bloating (analogue visual scale)
time frame: 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
Adherence to the planned bowel cleansing method (questionnaire)
time frame: 6 hours after finishing bowel preparation
Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
time frame: 10 minutes after the colonoscopy
Adverse events
time frame: 30 days after the colonoscopy

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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.
Principal investigator Marco Antonio Alvarez González, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.