Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— EII_Prep  

Official title:

Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411017
• Other study ID #: EII_Prep
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 20, 2021

Study information

• Verified date: May 2020
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.

Description:

Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 20, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients between 18y and 90y

• Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy

Exclusion Criteria:

• Patients <18y or >90y

• Pregnant Women

• Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study

• Patients with a history of bowel resection

• Patients undergoing therapeutic colonoscopy

• Patients unable to understand study protocol

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• Endoscopy
Colonoscopy

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid	Madrd

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel cleansing	Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.	1 year
Secondary	Treatment related adverse events	Number of Participants with symptomatology related to intervention in each arm of the study	1 year
Secondary	Preparation Tolerability: total volume of solution finally taken by the patient	Evaluation of total volume of solution finally taken by the patient	1 year