Feasibility and Effectiveness of Colonic Irrigation

Not Applicable

Terminated

• Conditions: Colonic Irrigation
• Interventions: Procedure: Colonic Irrigation

• Registration Number: NCT02826967
• Lead Sponsor: NYU Langone Health

Brief Summary

This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.

Detailed Description

The primary endpoints for this study are:

* Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6).

* Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Status Verified: 2020-06
• Primary Completion: 2020-06-08
• Study Completion: 2020-06-08
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy
• Ability to give consent

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Exclusion Criteria

• Pregnancy
• History of ulcerative colitis or Crohn's disease
• History of surgical ostomy
• History of colorectal surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonic Irrigation	Colonic Irrigation	A designated health professional will administer to the patient the colonic irrigation procedure -using the Hydro-San Plus colon therapy system, an FDA approved and ISO certified device for colonic irrigation and cleansing before endoscopic procedures (FDA #2027347).

Primary Outcome Measures

Name	Time	Method
Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS)	15 Minutes	Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score)
Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.	15 Minutes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States