Written Recommendation to Improve Adherence in Poor Bowel Preparation

Adherence, Patient Clinical Trial

Official title:

Written Endoscopist Recommendation to Improve Adherence to Early Repeat Colonoscopy Within 1 Year in Patients With Inadequate Bowel Preparation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709145
• Other study ID #: Endo-Remind
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Parc de Salut Mar
• Contact: Miguel Pantaleón, PhD MD
• Phone: +34 932 48 30 00
• Email: mapantaleon[@]psmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our study aims to improve adherence to international clinical guidelines of repeating colonoscopy within 1 year, when bowel cleansing has failed. To this end, we have designed an ambispective study in patients with inadequately prepared colonoscopy. An intervention group to which a precise written recommendation on the need to repeat the colonoscopy in less than 1 year is attached, compared with a control group to which no written recommendations are provided.

The sample size calculation is 171 patients per arm. In addition, we will quantify the percentage of pre-malignant and malignant lesions detected at repeat colonoscopy. We will also analyze factors that may be related to the recommendation or non-recommendation of repeat colonoscopy, as well as the association of variables related to adherence to repeat colonoscopy at an interval of less than 1 year.

Through our study, we intend to demonstrate that a written recommendation, easily applicable and generalizable, has a positive impact on adherence to clinical follow-up guidelines in patients in whom bowel cleansing has failed.

Description:

STUDY HYPOTHESIS

In patients with an inadequately prepared colonoscopy, a written recommendation on the need for repeat colonoscopy in less than 1 year improves adherence.

OBJECTIVES

Main objective

• To evaluate adherence to repeat colonoscopy in less than 1 year, after including an accurate written recommendation, versus not including a written recommendation, in patients with a colonoscopy with inadequate preparation.

Secondary objectives

• Determine the detection rate of adenomas, advanced adenomas, serrated lesions, and cancer in the different groups

• To identify risk factors predicting low adherence to repeat colonoscopy.

• To identify variables that influence the gastroenterologist-endoscopist to write down the need to repeat colonoscopy in less than 1 year.

METHODOLOGY

• Ambispective study in patients with inadequately prepared colonoscopy with a prospective inclusion intervention group to which a precise written recommendation on when the colonoscopy should be repeated is attached, compared with a retrospective cohort control group to which no written recommendations are given.

Study population

• Patients with an inadequately prepared colonoscopy for any indication except colorectal cancer screening.

There are 2 population groups according to the recommendations they received:

1. Control group: No-recommendation group.

Patients to be included in the retrospective cohort will receive a colonoscopy report that includes that the bowel cleansing was inadequate. However, the report will not include that the colonoscopy should be repeated in less than 1 year.

2. Intervention group: When-to-repeat group

Patients in the intervention group will receive a colonoscopy report that includes that the bowel cleansing was inadequate, and in addition the report will include that the colonoscopy should be repeated within 1 year.

Outcome measures

• Adherence to the recommendation will be considered a repeat colonoscopy at an interval of less than 1 year.

• Inadequate preparation will be evaluated according to the Boston Bowel Preparation Scale as less than 2 points in any segment.

• The physician requesting the baseline colonoscopy will be the one who should request the repeat colonoscopy, following the existing written recommendations and in case there are none, based on his clinical judgment.

• To assess the degree of bowel cleansing, we will use the Boston Bowel Preparation Scale (BBPS), which is the most validated of those available. This scale divides the colon into three segments, assigning each segment a score between 0 and 3 points. The overall score of the colon is between 0 and 9 points, with a higher score being understood as a better prepared colon in terms of cleanliness.

• Variables that are potentially related to leaving a written recommendation on the need to repeat and when by the physician-endoscopist will be collected: adenoma detection rate, experience of the endoscopist, full-time vs. partial-time.

• Variables potentially related to low adherence to repeat colonoscopy will be collected such as: patient age, indication for the test, colonoscopy findings (adenomas, advanced adenoma, ADK), physician requesting the examination (gastroenterologist/primary care/other specialists), patient nationality/language barrier, previous non-appearance, previous colonoscopies.

• To facilitate the written recommendation, in all patients with inadequate bowel preparation, a mandatory tab will be created to be filled in the colonoscopy report related to bowel preparation. In case of selecting inadequate cleansing, the recommendation to repeat the colonoscopy in an interval of less than 1 year will be automatically included in the report.

Sample size

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 171 subjects are necessary in first group and 171 in the second to find as statistically significant a proportion difference, expected to be of 0.3 in group 1 and 0.45 in group 2. It has been anticipated a drop-out rate of 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 342
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a colonoscopy with inadequate bowel preparation for any indication except for colorectal cancer screening

Exclusion Criteria:

• Patients with no indication for repeat colonoscopy due to clinical criteria

• Patients with a recommendation to repeat the colonoscopy with a different interval

• Hospitalized patients

• Patients with special reprogramming circuit (colorectal cancer screening, hospitalized patients, complex polypectomies, revision of polypectomies)

• Incomplete examination for other reasons than intestinal cleansing (stenosis, loops, etc...)

• Patients under 18 years of age

Related Conditions & MeSH terms

• Adherence, Patient
• Colonic Disease
• Colonic Diseases

Intervention

Other:
• Written recommendation
Patients in the intervention group will receive a report of the colonoscopy that will include a written recommendation that the colonoscopy should be repeated within1 year. The colonoscopy report will included that an adequate intestinal cleansing has not been achieved and therefore it is an invalid exploration. Additionally, a written recommendation indicating that the colonoscopy should be repeated within1 year will be included in the colonoscopy report. This recommendation is addressed both to the clinician who requested the colonoscopy and to the patient himself.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Atkin W, Wooldrage K, Brenner A, Martin J, Shah U, Perera S, Lucas F, Brown JP, Kralj-Hans I, Greliak P, Pack K, Wood J, Thomson A, Veitch A, Duffy SW, Cross AJ. Adenoma surveillance and colorectal cancer incidence: a retrospective, multicentre, cohort study. Lancet Oncol. 2017 Jun;18(6):823-834. doi: 10.1016/S1470-2045(17)30187-0. Epub 2017 Apr 28. — View Citation

Butterly LF, Nadel MR, Anderson JC, Robinson CM, Weiss JE, Lieberman D, Shapiro JA. Impact of Colonoscopy Bowel Preparation Quality on Follow-up Interval Recommendations for Average-risk Patients With Normal Screening Colonoscopies: Data From the New Hampshire Colonoscopy Registry. J Clin Gastroenterol. 2020 Apr;54(4):356-364. doi: 10.1097/MCG.0000000000001115. — View Citation

Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22. — View Citation

Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11. — View Citation

Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available. — View Citation

Schreuders E, Sint Nicolaas J, de Jonge V, van Kooten H, Soo I, Sadowski D, Wong C, van Leerdam ME, Kuipers EJ, Veldhuyzen van Zanten SJ. The appropriateness of surveillance colonoscopy intervals after polypectomy. Can J Gastroenterol. 2013 Jan;27(1):33-8. doi: 10.1155/2013/279897. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to repeat colonoscopy	Adherence to repeat colonoscopy within1 year in patients with inadequate bowel preparation colonoscopy.	1 year after index colonoscopy
Secondary	Overall adenoma detection rate	Ratio of patients with at least one adenoma lesion in the overall colon	At the moment of colonoscopy
Secondary	Overall serrated lesion detection rate	Ratio of patients with at least one serrated lesion in the overall colon	At the moment of colonoscopy
Secondary	Overall cancer detection rate	Ratio of patients with at least one cancer in the overall colon	At the moment of colonoscopy
Secondary	Complete colonoscopy rate	Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)	At the moment of colonoscopy
Secondary	Overall advanced adenoma detection rate	Ratio of patients with at least one advanced adenoma lesion in the overall colon	At the moment of colonoscopy
Secondary	Boston Bowel Preparation Scale	Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing	At the moment of colonoscopy