Feasibility and Effectiveness of Colonic Irrigation

Colonic Irrigation Clinical Trial

Official title:

Feasibility and Effectiveness of Colonic Irrigation as a Non-oral, Same-day Bowel Preparation Option in Patients Undergoing Screening or Surveillance Colonoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02826967
• Other study ID #: 16-00578
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 8, 2020

Study information

• Verified date: June 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Irrigation

Intervention

Procedure:
• Colonic Irrigation

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score)	15 Minutes
Primary	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