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Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04033250
Enrollment
600
Registered
2019-07-26
Start date
2019-09-30
Completion date
2020-12-31
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation

Brief summary

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.

Interventions

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

Bowel preparation

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improved bowel preparationIndex colonoscopyBoston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.

Countries

Israel

Contacts

Primary ContactKlein, MD
am_klein@rmc.gov.il+972-4-7773625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026