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

Parc de Salut Mar

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus; Colonic Diseases

Treatments: Drug: PEG-ascorbate 2L; Drug: PEG 4L

Study type: Interventional

Funder types: Other

Identifiers

NCT02297399

4790-I

Details and patient eligibility

About

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

Full 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

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

PEG-ascorbate 2L

Experimental group

Description:

Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.

Treatment:

Drug: PEG-ascorbate 2L

PEG 4L

Active Comparator group

Description:

Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.

Treatment:

Drug: PEG 4L