Written Recommendation to Improve Adherence in Poor Bowel Preparation

NCT05709145 | Completed

• 1 other identifier: Endo-Remind
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonic Disease; Adherence, Patient

Keywords

Colonoscopy; Bowel preparation; Quality; Written recommendation

Outcome Measures

Primary Outcomes (1)

• Adherence to repeat colonoscopy

  Adherence to repeat colonoscopy within1 year in patients with inadequate bowel preparation colonoscopy.

  1 year after index colonoscopy

Secondary Outcomes (6)

• Overall adenoma detection rate

  At the moment of colonoscopy

• Overall serrated lesion detection rate

  At the moment of colonoscopy

• Overall cancer detection rate

  At the moment of colonoscopy

• Complete colonoscopy rate

  At the moment of colonoscopy

• Overall advanced adenoma detection rate

  At the moment of colonoscopy

Study Arms (2)

Written recommendation

EXPERIMENTAL

Patients in the intervention group will receive a report of the colonoscopy that will include a written recommendation that the colonoscopy should be repeated within 1 year.

Other: Written recommendation

Non Written recommendation

NO INTERVENTION

Patients in the control group will receive a report of the colonoscopy without a written recommendation that the colonoscopy should be repeated within 1 year.

Interventions

Written recommendation OTHER

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.

Written recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (6)

• 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.

  PMID: 23378981 BACKGROUND

• 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.

  PMID: 28457708 BACKGROUND

• 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.

  PMID: 31295746 BACKGROUND

• 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.

  PMID: 22763141 BACKGROUND

• 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.

  PMID: 30106836 BACKGROUND

• 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.

  PMID: 32572858 BACKGROUND

MeSH Terms

Conditions

Colonic Diseases; Patient Compliance

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD at Hospital del Mar

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: May 11, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 13, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

ES (1)