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Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen
The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging
Randomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram.
Group 2 the participant recieved Polyethylene 4 liter split dose
Result of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Liter polyethylene glycol plus elobixibat | Experimental | Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m. |
|
| 4-Liter polyethylene glycol | Active Comparator | Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-Liter polyethylene glycol plus elobixibat | Drug | Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison efficacy of bowel preparation before colonoscopy between 2 group | Bowel preaparation measure by Boston bowel preparation scale | During colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall procedural time of colonoscopy | Duration since start colonoscopy insertion until withdrawal endoscope | During colonoscopy procedure |
| Cecal intubation rate | Perform successful endoscopy to cecum |
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Inclusion Criteria:
Adute aged 18-80 year old
Indication for colonoscopy(one selected)
Participant acceptconsent information
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Apichet Sirinawasatien, M.D. | Contact | 023548108 | sui_apichet@hotmail.com | |
| Somchai Uthiwamek, M.D. | Contact | 0851267424 | p3n_p1ng@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Apichet Sirinawasatien, M.D. | Department of Medical Services Ministry of Public Health of Thailand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Recruiting | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33971037 | Background | Yamaguchi D, Hidaka H, Matsunaga T, Akutagawa T, Tanaka Y, Jubashi A, Takeuchi Y, Tsuruoka N, Sakata Y, Miyahara K, Tominaga N, Kawakubo H, Takamori A, Shimoda R, Noda T, Ogata S, Tsunada S, Esaki M. Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study. Dig Endosc. 2022 Jan;34(1):171-179. doi: 10.1111/den.14010. Epub 2021 May 24. | |
| 28840422 |
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No plan for IPD sharing
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| 4-Liter polyethylene glycol | Drug | Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m. |
|
| During colonoscopy procedure |
| Withdrawal time of colonoscopy | Duration since endoscopy withdrawal from cecum to anal canal | During colonoscopy procedure |
| Adenoma detection rate | At least one adenoma presented in this colonoscopy | During colonoscopy procedure |
| Patient satisfaction in their bowel preparation regimen | Satisfaction score evaluate by Linkert scale | 1 day before colonoscopy |
| Adverse event in each group | Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema | During 24 hour after taking bowel preparation |
| Background |
| Nakajima A, Seki M, Taniguchi S. Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial. J Gastroenterol. 2018 Apr;53(4):525-534. doi: 10.1007/s00535-017-1383-5. Epub 2017 Aug 24. |
| 27446836 | Background | Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13. |
| 20883845 | Background | 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. |
| 19136102 | Background | Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. |
| 26232311 | Background | Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6. |
| 25057297 | Background | Acosta A, Camilleri M. Elobixibat and its potential role in chronic idiopathic constipation. Ther Adv Gastroenterol. 2014 Jul;7(4):167-75. doi: 10.1177/1756283X14528269. |
| 30793431 | Background | Nakajima A, Taniguchi S, Kurosu S, Gillberg PG, Mattsson JP, Camilleri M. Efficacy, long-term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan. Neurogastroenterol Motil. 2019 May;31(5):e13571. doi: 10.1111/nmo.13571. Epub 2019 Feb 21. |
| 12135020 | Background | 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. doi: 10.1111/j.1572-0241.2002.05827.x. |
| ID | Term |
|---|---|
| C581303 | elobixibat |
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