Feasibility and Effectiveness of Colonic Irrigation

NYU Langone Health

Status: Terminated

Conditions: Colonic Irrigation

Treatments: Procedure: Colonic Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02826967

16-00578

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 50 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Colonic Irrigation

Experimental group

Description:

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).

Treatment:

Procedure: Colonic Irrigation