Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

Diabetes Mellitus Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297399
• Other study ID #: 4790-I
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2014
• Last updated: February 21, 2017
• Start date: December 2, 2014
• Est. completion date: January 26, 2016

Study information

• Verified date: February 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 26, 2016
• Est. primary completion date: January 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Diabetes Mellitus

Intervention

Drug:
• PEG-ascorbate 2L
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.
• PEG 4L
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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Rünzi M, Schneider T, Kachel G, Grüger J, Köllinger 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Abdominal pain, nausea and bloating (analogue visual scale)	Each participant will rate his/her experience in an analogue visual scale.	6 hours after finishing bowel preparation
Secondary	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
Secondary	Adherence to the planned bowel cleansing method (questionnaire)	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation
Secondary	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
Secondary	Adverse events	Description of any adverse event occurred during the study period	30 days after the colonoscopy