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| Name | Class |
|---|---|
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| Wuhan Central Hospital | OTHER |
| Wuhan Third Hospital | OTHER |
| The General Hospital of Central Theater Command |
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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.
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 high risk if they have 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG (low-risk patients and high-risk patients) | Placebo Comparator | The dosing regimen of low-risk patients and high-risk patients will only be PEG. |
|
| PEG+lactulose (low-risk patients and high-risk patients) | Experimental | The dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale | 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. | during colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate | Diagnosis was confirmed by histologic examination | 2 days |
| Rate of adverse events | adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain. |
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Inclusion Criteria:
- Adults undergoing colonoscopy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingkai Chen, M.D | Renmin Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25595062 | Background | 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. No abstract available. | |
| 31295746 |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| OTHER |
| The Third People's Hospital of Hubei Province | OTHER |
| Wuhan Puren Hospital | OTHER |
| Wuhan Pu-Ai Hospital | OTHER |
| Tianyou Hospital Affiliated to Wuhan University of Science and Technology | OTHER |
| Wuhan Red Cross Hospital | UNKNOWN |
Patients scheduled for colonoscopy were stratified into low- and high-risk patients based on the inclusion criteria. Low- and high-risk patients were randomized to the PEG alone or lactulose combined with PEG group respectively.
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The allocation assignment of patients was performed by a designated technician at each center based on a computer-generated random sequence. The designated technician was not involved in the colonoscopy procedure.
|
| PEG+lactulose | Drug | 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. |
|
|
| 2 days |
| Cecal intubation rate | Colonoscopy reaches cecal region. | during colonoscopy |
| Cecal intubation time | Colonoscopy reaches cecal region. | during colonoscopy |
| Withdrawal time | The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps. | during colonoscopy |
| defecation frequency | Frequency of bowel movement. | 2 days |
| Willingness to repeat bowel preparation | The number of patients have a willingness to undergo a repeated bowel preparation if needed. | 2 days |
| Background |
| 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, Pellise 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. |
| 28985630 | Background | 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. |
| 29533397 | Background | 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. |
| 26658804 | Background | 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. |
| D000073893 |
| Sugars |