Clinical trial NCT02297399: Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Colonic Diseases
Keywords: Colonoscopy
Diabetes Mellitus
Polyethylene glycols
Ascorbate
Personal satisfaction
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2014-11-21
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Tolerability of the bowel preparation (analogue visual scale)
timeFrame: 6 hours after finishing bowel preparation
Secondary outcomes:
measure: Ease of consumption and taste of the laxative (analogue visual scale)
timeFrame: 6 hours after finishing bowel preparation
measure: Abdominal pain, nausea and bloating (analogue visual scale)
timeFrame: 6 hours after finishing bowel preparation
measure: Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
timeFrame: 6 hours after finishing bowel preparation
measure: Adherence to the planned bowel cleansing method (questionnaire)
timeFrame: 6 hours after finishing bowel preparation
measure: Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
timeFrame: 10 minutes after the colonoscopy
measure: Adverse events
timeFrame: 30 days after the colonoscopy
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar
name: Marco Antonio Alvarez González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.