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| Name | Class |
|---|---|
| Germans Trias i Pujol Hospital | OTHER |
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This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-ascorbate 2L | Experimental | Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution. |
|
| PEG 4L | Active Comparator | Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the bowel preparation (analogue visual scale) | Each participant will rate his/her experience in an analogue visual scale. | 6 hours after finishing bowel preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of consumption and taste of the laxative (analogue visual scale) | Each participant will rate his/her experience in an analogue visual scale. | 6 hours after finishing bowel preparation |
| Abdominal pain, nausea and bloating (analogue visual scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Antonio Alvarez González, MD, PhD | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9744604 | Background | 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. | |
| 10968848 | Background | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003108 | Colonic Diseases |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| 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. |
|
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Each participant will rate his/her experience in an analogue visual scale.
| 6 hours after finishing bowel preparation |
| Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire) | Each participant will rate his/her experience in a questionnaire. | 6 hours after finishing bowel preparation |
| Adherence to the planned bowel cleansing method (questionnaire) | Each participant will rate his/her experience in a questionnaire. | 6 hours after finishing bowel preparation |
| Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS) | Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist | 10 minutes after the colonoscopy |
| Adverse events | Description of any adverse event occurred during the study period | 30 days after the colonoscopy |
| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| 11280539 | Background | 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. |
| 19582466 | Background | 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. |
| 18190651 | Background | 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. |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |