Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Rambam Health Care Campus

Status: Unknown

Conditions: Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation

Treatments: Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04033250

0117-19-RMB CTIL

Details and patient eligibility

About

Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.

The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• previous IBP
• concurrent medical conditions (e.g. diabetes, constipation)
• medications (e.g. opioids and tricyclic antidepressants)

Exclusion criteria

• previous colonic resection
• patients with IBD
• active CRC
• chronic kidney disease at any stage
• congestive heart failure at any stage
• liver cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Interventional arm (group A)

Experimental group

Description:

Patients with risk factors for IBP who will receive "intensified" bowel preparation

Treatment:

Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure

Control arm (group B)

Active Comparator group

Description:

Patients with risk factors for IBP who will receive standard bowel preparation

Treatment:

Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure

Control arm (group c)

Active Comparator group

Description:

Patients without risk factors for IPB who will receive standard bowel preparation

Treatment:

Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure