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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03458377
Other study ID # ESTRELLA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2018
Est. completion date October 31, 2018

Study information

Verified date February 2018
Source Parc de Salut Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses what impact has on colonoscopy quality the implementation of a telephone educational intervention carried out individually on the patient in the days before the test. Half of the study patients will receive the educational intervention and the other half will not.


Description:

A high-quality colonoscopy is an examination in with patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.

But quality also refers to pre-procedure and post-procedure quality issues such as information, booking, choice, privacy, dignity, aftercare and satisfaction of patients. All those issues can negatively affect the willingness of patients to perform the test and the possibility of preparing adequately. And what is more, it can diminish the quality of the own exploration, the satisfaction of the patients and their adherence to programs of endoscopic follow-up.

An action on these colonoscopy non-technical issues with a telephone educational intervention performed by the gastrointestinal endoscopy nurse can positively improve all (pre, intra and post-procedure) colonoscopy quality indicators.


Recruitment information / eligibility

Status Completed
Enrollment 1534
Est. completion date October 31, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All outpatient referred from the Primary Care Centers to perform a colonoscopy in our Digestive Endoscopy Unit, regardless of the applicant's Service.

Exclusion Criteria:

- Hospital patients, patients who refuse inclusion in the study, patients included in another study, impossibility of carrying out the educational intervention and patients who are unable to obtain informed consent will be excluded from the study.

Study Design


Intervention

Other:
Educational telephone call
Explanation of the importance of making the test. Guidelines for the usual medication of the patient. Definition of fasting, explanation of colon cleansing adjusted to the presence of predictors of poor basic preparation. Explanation of the endoscopic procedure with the elimination of erroneous concepts of the patient with respect to the procedure. Explanation of norms of action subsequent to the endoscopy. Management of scheduling, destined to improve the adherence of the patient for the test.

Locations

Country Name City State
Spain Parc de Salut Mar. Hospital del Mar Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuñiga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. Epub 2016 Aug 4. — View Citation

Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16. — View Citation

Sola-vera J, Sáez J, Laveda R, Girona E, García-Sepulcre MF, Cuesta A, Vázquez N, Uceda F, Pérez E, Sillero C. Factors associated with non-attendance at outpatient endoscopy. Scand J Gastroenterol. 2008;43(2):202-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Colonoscopy non-adherence rate Ratio of patients do not attend the test At the moment of colonoscopy
Secondary Antiplatelet / anticoagulant rescheduling rate Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test At the moment of colonoscopy
Secondary Anesthetist rescheduling rate Ratio of patients attend the colonoscopy with American Society of Anesthesiologists (ASA) III / IV classification so they need rescheduling of the test under anesthesia At the moment of colonoscopy
Secondary Bowel preparation rescheduling rate Ratio of patients attend the colonoscopy with inadequate Boston Bowel Preparation Scale (at least one of the colon segments with less than 2 points) so they need rescheduling of the test At the moment of colonoscopy
Secondary Adenoma detection rate Ratio of patients with at least one adenoma in the colon At the moment of colonoscopy
Secondary Cecal intubation rate Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis) At the moment of colonoscopy
Secondary Satisfaction of the endoscopic procedure Measurement of the overall satisfaction of the colonoscopy with a questionnaire validated by the American Society for Gastrointestinal Endoscopy (ASGE) 30 days after colonoscopy
Secondary Complications related to colonoscopy Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test 30 days after colonoscopy
Secondary Non-adequation colonoscopy cost of patient preparation for colonoscopy Cost derived from non-adequation From date of randomization until 30 days before colonoscopy
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