Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients (iDIMEPREP)
Primary Purpose
Diabetes Mellitus, Colonic Diseases
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
PEG-ascorbate 2L
PEG 4L
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus focused on measuring Colonoscopy, Diabetes Mellitus, Polyethylene glycols, Ascorbate, Personal satisfaction
Eligibility Criteria
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
Sites / Locations
- Hospital Germans Trias i Pujol
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PEG-ascorbate 2L
PEG 4L
Arm Description
Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
Outcomes
Primary Outcome Measures
Tolerability of the bowel preparation (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Secondary Outcome Measures
Ease of consumption and taste of the laxative (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Abdominal pain, nausea and bloating (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
Each participant will rate his/her experience in a questionnaire.
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Adverse events
Description of any adverse event occurred during the study period
Full Information
NCT ID
NCT02297399
First Posted
November 13, 2014
Last Updated
February 21, 2017
Sponsor
Parc de Salut Mar
Collaborators
Germans Trias i Pujol Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02297399
Brief Title
Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients
Acronym
iDIMEPREP
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2, 2014 (Actual)
Primary Completion Date
January 26, 2016 (Actual)
Study Completion Date
January 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Germans Trias i Pujol Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Colonic Diseases
Keywords
Colonoscopy, Diabetes Mellitus, Polyethylene glycols, Ascorbate, Personal satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-ascorbate 2L
Arm Type
Experimental
Arm Description
Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
Arm Title
PEG 4L
Arm Type
Active Comparator
Arm Description
Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
Intervention Type
Drug
Intervention Name(s)
PEG-ascorbate 2L
Other Intervention Name(s)
Moviprep®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PEG 4L
Other Intervention Name(s)
Bohm®
Intervention Description
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 Outcome Measure Information:
Title
Tolerability of the bowel preparation (analogue visual scale)
Description
Each participant will rate his/her experience in an analogue visual scale.
Time Frame
6 hours after finishing bowel preparation
Secondary Outcome Measure Information:
Title
Ease of consumption and taste of the laxative (analogue visual scale)
Description
Each participant will rate his/her experience in an analogue visual scale.
Time Frame
6 hours after finishing bowel preparation
Title
Abdominal pain, nausea and bloating (analogue visual scale)
Description
Each participant will rate his/her experience in an analogue visual scale.
Time Frame
6 hours after finishing bowel preparation
Title
Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
Description
Each participant will rate his/her experience in a questionnaire.
Time Frame
6 hours after finishing bowel preparation
Title
Adherence to the planned bowel cleansing method (questionnaire)
Description
Each participant will rate his/her experience in a questionnaire.
Time Frame
6 hours after finishing bowel preparation
Title
Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
Description
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Time Frame
10 minutes after the colonoscopy
Title
Adverse events
Description
Description of any adverse event occurred during the study period
Time Frame
30 days after the colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Alvarez González, MD, PhD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
9744604
Citation
Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998 Sep;48(3):276-82. doi: 10.1016/s0016-5107(98)70191-9.
Results Reference
background
PubMed Identifier
10968848
Citation
Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
Results Reference
background
PubMed Identifier
11280539
Citation
Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x.
Results Reference
background
PubMed Identifier
19582466
Citation
Ozturk NA, Gokturk HS, Demir M, Erdogan D, Unler GK, Gur G, Yilmaz U. The effect of autonomous neuropathy on bowel preparation in type 2 diabetes mellitus. Int J Colorectal Dis. 2009 Dec;24(12):1407-12. doi: 10.1007/s00384-009-0757-4. Epub 2009 Jul 7.
Results Reference
background
PubMed Identifier
18190651
Citation
Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.
Results Reference
background
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Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients
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