Colonic DiseaseNCT05709145
Written Recommendation to Improve Adherence in Poor Bowel Preparation
A study testing Written recommendation in people with Colonic Disease and Adherence, Patient, run by Parc de Salut Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Disease, Adherence, Patient
- What is being tested?
- Written recommendation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2023to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a colonoscopy with inadequate bowel preparation for any indication except for colorectal cancer screening
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Written Endoscopist Recommendation to Improve Adherence to Early Repeat Colonoscopy Within 1 Year in Patients With Inadequate Bowel Preparation.
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.
Read the detailed 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:
- 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.
- 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%.
- Conditions
- Colonic Disease, Adherence, Patient
- Being tested
- Written recommendation
- Keywords
- Colonoscopy, Bowel preparation, Quality, Written recommendation
- Medical subject headings
- Colonic Diseases, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written recommendationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to repeat colonoscopy
Adherence to repeat colonoscopy within1 year in patients with inadequate bowel preparation colonoscopy.
Measured: 1 year after index colonoscopy
Secondary outcomes (6)
Overall adenoma detection rate
Ratio of patients with at least one adenoma lesion in the overall colon
Measured: At the moment of colonoscopy
Overall serrated lesion detection rate
Ratio of patients with at least one serrated lesion in the overall colon
Measured: At the moment of colonoscopy
Overall cancer detection rate
Ratio of patients with at least one cancer in the overall colon
Measured: At the moment of colonoscopy
Complete colonoscopy rate
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
Measured: At the moment of colonoscopy
Overall advanced adenoma detection rate
Ratio of patients with at least one advanced adenoma lesion in the overall colon
Measured: At the moment of colonoscopy
Boston Bowel Preparation Scale
Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
Measured: At the moment of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start11 May 2023
- Primary completion31 Dec 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Angel Pantaleon Sanchez, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709145
- Sponsor's protocol ID
- Endo-Remind
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23378981Atkin 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.
PubMed 28457708Hassan 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.
PubMed 31295746Lieberman 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.
PubMed 22763141Butterly 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.
PubMed 30106836Hassan 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.
PubMed 32572858Anton Arnal M, Grima Sopesens N, Seoane Urgorri A, Duran Jorda X, Batlle Garcia M, Parrilla Carrasco M, Pont Feijoo E, Mane Bosch A, Munoz Galito J, Riu Pons F, Dedeu Cusco JM, Bessa Caserras X, Barranco Priego L, Pantaleon Sanchez MA. Written Recommendation to Repeat Colonoscopy within 1 Year after Inadequate Bowel Preparation: A Simple and Highly Effective Intervention. Endosc Int Open. 2026 Oct 16;14:a29737245. doi: 10.1055/a-2973-7245. eCollection 2026.
PubMed 42898906
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Endoscopist Recommendation to Improve Adherence to Early Repeat Colonoscopy Within 1 Year in Patients With Inadequate Bowel Preparation.
- ClinicalTrials.gov ID
- NCT05709145
- Acronym / sponsor ID
- Endo-Remind
- Conditions
- Colonic Disease, Adherence, Patient
- Keywords
- Colonoscopy, Bowel preparation, Quality, Written recommendation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written recommendation | Experimental | Other: Written recommendationPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a colonoscopy with inadequate bowel preparation for any indication except for colorectal cancer screening
Key exclusion criteria (6 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written recommendationPatients 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. | Other | Written recommendation |
Primary outcome
Adherence to repeat colonoscopy
Time frame: 1 year after index colonoscopy
Adherence to repeat colonoscopy within1 year in patients with inadequate bowel preparation colonoscopy.
6 secondary outcomes
Overall adenoma detection rate
Time frame: At the moment of colonoscopy
Overall serrated lesion detection rate
Time frame: At the moment of colonoscopy
Overall cancer detection rate
Time frame: At the moment of colonoscopy
Complete colonoscopy rate
Time frame: At the moment of colonoscopy
Overall advanced adenoma detection rate
Time frame: At the moment of colonoscopy
Boston Bowel Preparation Scale
Time frame: At the moment of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 23378981Schreuders 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.
- Background: PubMed 28457708Atkin 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.
- Background: PubMed 31295746Hassan 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.
- Background: PubMed 22763141Lieberman 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.
- Background: PubMed 30106836Butterly 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.
- Background: PubMed 32572858Hassan 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.
- Derived from this study: PubMed 42898906Anton Arnal M, Grima Sopesens N, Seoane Urgorri A, Duran Jorda X, Batlle Garcia M, Parrilla Carrasco M, Pont Feijoo E, Mane Bosch A, Munoz Galito J, Riu Pons F, Dedeu Cusco JM, Bessa Caserras X, Barranco Priego L, Pantaleon Sanchez MA. Written Recommendation to Repeat Colonoscopy within 1 Year after Inadequate Bowel Preparation: A Simple and Highly Effective Intervention. Endosc Int Open. 2026 Oct 16;14:a29737245. doi: 10.1055/a-2973-7245. eCollection 2026.
Related trials for Colonic Disease
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written recommendation in people with Colonic Disease and Adherence, Patient, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to repeat colonoscopy (time frame: 1 year after index colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709145, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.