Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Procedure: Endoscopy

• Registration Number: NCT04411017
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-07-24
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-20
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1L PEG	Endoscopy	-
2L PEG	Endoscopy	-
2L sodium picosulfate	Endoscopy	-

Primary Outcome Measures

Name	Time	Method
Bowel cleansing	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Treatment related adverse events	1 year	Number of Participants with symptomatology related to intervention in each arm of the study
Preparation Tolerability: total volume of solution finally taken by the patient	1 year	Evaluation of total volume of solution finally taken by the patient

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Madrd, Spain