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OpenTrials
Completed

NCT Number: NCT04411017

Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, Madrd, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy

Procedure

Colonoscopy

Primary outcomes

  1. Bowel cleansing

    Time frame: 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 outcomes

  1. Treatment related adverse events

    Time frame: 1 year

    Number of Participants with symptomatology related to intervention in each arm of the study

  2. Preparation Tolerability: total volume of solution finally taken by the patient

    Time frame: 1 year

    Evaluation of total volume of solution finally taken by the patient

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Acronym: EII_Prep

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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