Colonic Irrigation for Colonoscopy Preparation

Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647229

Enrollment

Registered

2016-01-06

Start date

2014-10-31

Completion date

2016-10-31

Last updated

2016-09-28

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

Conditions

Colonoscopy

Brief summary

The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.

Interventions

OTHERIsosmotic bowel cleansing preparation

Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.

OTHERColonic Hyrdrotherapy

FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician

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

Inclusion criteria

* Consecutive adult patients (\>18 years old) who require screening or surveillance colonoscopy * Ability to give consent

Exclusion criteria

* Inability to obtain informed consent * Pregnant patients * Patients under the age of 18 * Active ulcerative colitis or crohn's disease flare * Prisoners

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Boston Bowel Prep Score (BBPS)	1 Day	Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)

Secondary

Measure	Time frame
Difference in Adenoma Detection Rate (ADR)	1 Day
Difference in the number of follow ups needed after colonoscopy	1 Day
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)	1 Day
preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)	1 Day

Countries

United States

Outcome results

None listed

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