Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as low risk if they any of the above factors and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: PEG (low-risk patients and high-risk patients) The dosing regimen of low-risk patients and high-risk patients will only be PEG. |
Drug: PEG
Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.
Other Names:
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| Experimental: PEG+lactulose (low-risk patients and high-risk patients) The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose. |
Drug: PEG+lactulose
On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Boston Bowel Preparation Scale [during colonoscopy]
Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.
Secondary Outcome Measures
- Adenoma Detection Rate [2 days]
Diagnosis was confirmed by histologic examination
- Rate of adverse events [2 days]
adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain.
- Cecal intubation rate [during colonoscopy]
Colonoscopy reaches cecal region.
- Cecal intubation time [during colonoscopy]
Colonoscopy reaches cecal region.
- Withdrawal time [during colonoscopy]
The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.
- defecation frequency [2 days]
Frequency of bowel movement.
- Willingness to repeat bowel preparation [2 days]
The number of patients have a willingness to undergo a repeated bowel preparation if needed.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adults undergoing colonoscopy.
Exclusion Criteria:
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1.presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
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2.Patients with galactosemia;
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- hypersensitivity to any of the ingredients;
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4.Pregnancy or lactation;
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5.Use of lactulose,prokinetic agents or purgatives within 7 days;
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6.Unwilling to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
Sponsors and Collaborators
- Renmin Hospital of Wuhan University
- Hubei Hospital of Traditional Chinese Medicine
- Wuhan Central Hospital
- Wuhan Third Hospital
- The General Hospital of Central Theater Command
- The Third People's Hospital of Hubei
- Wuhan Puren Hospital
- Wuhan Puai Hospital
- Tian You Hospital Affiliated to Wuhan University of Science and Technology
- Wuhan Red Cross Hospital
Investigators
- Principal Investigator: Mingkai Chen, M.D, Renmin Hospital of Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.
- Hassan 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, Pellisé 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.
- Kang X, Zhao L, Zhu Z, Leung F, Wang L, Wang X, Luo H, Zhang L, Dong T, Li P, Chen Z, Ren G, Jia H, Guo X, Pan Y, Guo X, Fan D. Same-Day Single Dose of 2 Liter Polyethylene Glycol is Not Inferior to The Standard Bowel Preparation Regimen in Low-Risk Patients: A Randomized, Controlled Trial. Am J Gastroenterol. 2018 Apr;113(4):601-610. doi: 10.1038/ajg.2018.25. Epub 2018 Mar 13.
- Lu J, Cao Q, Wang X, Pu J, Peng X. Application of Oral Lactulose in Combination With Polyethylene Glycol Electrolyte Powder for Colonoscopy Bowel Preparation in Patients With Constipation. Am J Ther. 2016 Jul-Aug;23(4):e1020-4. doi: 10.1097/MJT.0000000000000351.
- 2019-X2-73