Colonic Neoplasms Clinical Trial
Official title:
A 3-day Versus 1-day Low Residue Diet to Improve Colonoscopy Preparation Result and Patient Tolerability: A Prospective, Randomized, Single-blinded, Controlled Trial
Verified date | July 2019 |
Source | Portuguese Oncology Institute, Coimbra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Colonoscopy is one of the most common methods for the diagnosis and treatment of lower
gastrointestinal tract diseases and provides a unique opportunity to identify early
neoplastic lesions.
Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing
regimens, study of patient-related risk factors to fail a proper preparation and diet
adaptations have been studied recently.
A low residue diet is the standard in the day before the colonoscopy. Some endoscopists
prescribe this dietary plan for a 3-day period prior to the exam, although no study compared
the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation
results.
The aim of this project is to determine if the use of a 3-day low residue diet improves bowel
preparations results and the influence in patient tolerability and adherence.
Status | Completed |
Enrollment | 412 |
Est. completion date | May 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive series of patients scheduled for total colonoscopy - Signed informed consent Exclusion Criteria: - inpatients - sedation - urgent procedures - colonoscopies not intended to reach the caecum - patient with previous partial colectomy. |
Country | Name | City | State |
---|---|---|---|
Portugal | Portuguese Oncology Institute - Coimbra | Coimbra |
Lead Sponsor | Collaborator |
---|---|
Portuguese Oncology Institute, Coimbra |
Portugal,
ASGE Standards of Practice Committee, Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. — View Citation
Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19. Review. — View Citation
Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068. — View Citation
Cohen LB. Advances in bowel preparation for colonoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):183-97. doi: 10.1016/j.giec.2014.11.003. Epub 2015 Jan 9. Review. — View Citation
Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18. — View Citation
Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200. — View Citation
Lijoi D, Ferrero S, Mistrangelo E, Casa ID, Crosa M, Remorgida V, Alessandri F. Bowel preparation before laparoscopic gynaecological surgery in benign conditions using a 1-week low fibre diet: a surgeon blind, randomized and controlled trial. Arch Gynecol Obstet. 2009 Nov;280(5):713-8. doi: 10.1007/s00404-009-0986-3. Epub 2009 Feb 20. — View Citation
Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13. Review. — View Citation
Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19. Review. — View Citation
Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. Review. — View Citation
Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432. Review. — View Citation
Vanhauwaert E, Matthys C, Verdonck L, De Preter V. Low-residue and low-fiber diets in gastrointestinal disease management. Adv Nutr. 2015 Nov 13;6(6):820-7. doi: 10.3945/an.115.009688. Print 2015 Nov. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patients characteristics questionnaire | Evaluate, using proper data collecting sheet, patient relevant data (age, gender, chronic medication, risk factors for inappropriate preparation) | 1 day | |
Primary | Score of mucosal visualization | Using Boston Bowel Preparation Scale during the exam | 1 day (during colonoscopy) | |
Secondary | Patient assessment of diet protocol | Patient assessment, by written questionnaire, of tolerance and acceptance of diet protocol. | 1 day (the day of the exam) | |
Secondary | Polyp detection rate, location and configuration | One of the quality indicators for colonoscopy is polyp detection rate, which is defined as the percentage of colonoscopies with a detection of at least one polyp. At the same time the endoscopist will assign the colonic location of the polyp (ascendent, transverse, descendent). (PDR to be presented as %; Location to be discriminated in the endoscopist report). |
1 day (during colonoscopy) | |
Secondary | Adenoma Detection Rate | Adenoma detection rate (ADR) is the one of the strongest quality indicators for colonoscopy. This rate represents the percentage of colonoscopies with at least one adenoma identified. (to be presented as %) | Within 30 days from colonoscopy date | |
Secondary | Cecum intubation rate | Defined as colonoscopy quality indicator the photo documentation of cecum, in at least 95% of the colonoscopies. Photo documentation of the cecum is a mark for effective total colonoscopy. (to presented as %) | 1 day (during colonoscopy) | |
Secondary | Withdrawal time | In a negative colonoscopy (no polyp identification) is defined that the withdrawal time should be at least 6 minutes for proper and safe colonic mucosa evaluation. (to be presented in minutes) | 1 day (during colonoscopy) |
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