Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

NCT02297399 | Completed Phase 3

• 1 other identifier: 4790-I
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabetes Mellitus; Colonic Diseases

Keywords

Colonoscopy; Diabetes Mellitus; Polyethylene glycols; Ascorbate; Personal satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Ease of consumption and taste of the laxative (analogue visual scale)

  6 hours after finishing bowel preparation

• Abdominal pain, nausea and bloating (analogue visual scale)

  6 hours after finishing bowel preparation

• Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)

  6 hours after finishing bowel preparation

• Adherence to the planned bowel cleansing method (questionnaire)

  6 hours after finishing bowel preparation

• Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)

  10 minutes after the colonoscopy

Study Arms (2)

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.

Drug: PEG-ascorbate 2L

PEG 4L

ACTIVE COMPARATOR

Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.

Drug: PEG 4L

Interventions

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.

Also known as: Moviprep®

PEG-ascorbate 2L

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.

Also known as: Bohm®

PEG 4L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
• Diabetes mellitus (being treated with insulin or any oral agent).

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (2)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (5)

• 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.

  PMID: 9744604 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.

  PMID: 10968848 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.

  PMID: 11280539 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.

  PMID: 19582466 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.

  PMID: 18190651 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Colonic Diseases; Personal Satisfaction

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavior

Study Officials

• Marco Antonio Alvarez González, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 21, 2014
• Study Start: December 2, 2014
• Primary Completion: January 26, 2016
• Study Completion: January 26, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

ES (2)