Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

Phase 3

Completed

• Conditions: Colonic Diseases; Diabetes Mellitus
• Interventions: Drug: PEG 4L; Drug: PEG-ascorbate 2L

• Registration Number: NCT02297399
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-21
• Study Start: 2014-12-02
• Primary Completion: 2016-01-26
• Study Completion: 2016-01-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG 4L	PEG 4L	Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
PEG-ascorbate 2L	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.

Primary Outcome Measures

Name	Time	Method
Tolerability of the bowel preparation (analogue visual scale)	6 hours after finishing bowel preparation	Each participant will rate his/her experience in an analogue visual scale.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain