Colon Polyp Clinical Trial
Official title:
Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.
NCT number | NCT04898426 |
Other study ID # | GriffithBH |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 13, 2021 |
Est. completion date | March 2022 |
Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | March 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Elective colonoscopy booking at Griffith Base Hospital. Exclusion Criteria: - Emergency colonoscopy - Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin. |
Country | Name | City | State |
---|---|---|---|
Australia | Griffith Base Hospital | Griffith | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Griffith Base Hospital |
Australia,
Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18. — View Citation
Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28. — View Citation
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Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017 Jan;85(1):90-97.e6. doi: 10.1016/j.gie.2016.05.012. Epub 2016 May 14. Review. — View Citation
Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. — View Citation
Janahiraman S, Tay CY, Lee JM, Lim WL, Khiew CH, Ishak I, Onn ZY, Ibrahim MR, Chew CK. Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial. BMJ Open Gastroenterol. 2020 May;7(1). pii: e000376. doi: 10.1136/bmjgast-2020-000376. — View Citation
Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20. — View Citation
Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16. — 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
Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. — View Citation
Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12. — View Citation
Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bowel preparation quality | Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality) | Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months. | |
Secondary | Colonoscopy cancellation rate | The number of colonoscopy being cancelled within 48 hours of the colonoscopy date. The rates will be compared between the study groups. | Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months. | |
Secondary | Caecal intubation rate | The proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon. The rates will be compared between the study groups. | Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months. | |
Secondary | Polyp detection rate | The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups. | Polyp detection rate will be calculated at the time of study completion, expected to be 12 months. |
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