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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Hospital of Integrated Traditional Chinese and Western Medicine | UNKNOWN |
| China-japan Friendship Hospital, Jilin University |
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To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy
Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSS group | Experimental | Bowel preparation for colonoscopy was performed using oral sulfate solution as laxative |
|
| Polyethylene glycol group | Active Comparator | Bowel preparation for colonoscopy was performed using polyethylene glycol as laxative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral sulfate solution (OSS) | Drug | OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel preparation adequate rate | Proportion of subjects with total Boston bowel preparation scale (BBPS) score (total colon) ≥6. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Boston bowel preparation scale (BBPS) score | The BBPS scoring rules: 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid; 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation. 3 intestinal segments were scored separately: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). Total BBPS score (0-9, the higher the score, the better the quality of bowel preparation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li.zhaoshen@hotmail.com li.zhaoshen@hotmail.com, M.D. | Changhai Hospital, Naval Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28648575 | Background | Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23. | |
| 25239068 | Background |
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| ID | Term |
|---|---|
| C084115 | glycoprep |
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| Beijing Hospital | OTHER_GOV |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Zhongshan Hospital Xiamen University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Hebei Provincial People's Hospital | UNKNOWN |
| Shandong University Qilu Hospital | UNKNOWN |
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| Polyethylene Glycol Electrolyte | Drug | Take 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy. |
|
| 30 minutes |
| Acceptability of laxatives by questionnaire survey | The proportion of people who accept the laxative. Level I: the laxative has good taste and is easy to take; the intestinal clearing fluid is drunk smoothly; the intestinal preparation process is easily tolerated; Level II: The laxative has a general taste and is easy to take. The intestinal fluid is basically drunk on time, and the intestinal preparation process is barely tolerated; Level III: unacceptable laxative taste, difficult to take medicine, unable to drink the clear bowel fluid on time, intolerable bowel preparation process, refuse similar experience in the future. Under level I and Level II, the laxative was considered to be acceptable. Under level III, the laxative was considered not to be acceptable. | 12 hours |
| Colonoscopy completion rate | Proportion of subjects receiving complete colonoscopy | 30 minutes |
| Incidence of laxative-related adverse events assessed by clinical examinations | Physical examination (skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, limbs), vital signs (temperature, respirations, heart rate, blood pressure), blood routine, urine routine, blood biochemistry (DBIL, TBIL, UREA, Cr, AST, ALT, TP, ALB, GLU, TG, TC, CK, ALP, K, Na, Cl, Ca, Mg, UA), coagulation function, and 12-lead electrocardiogram were performed within 7 days before taking laxatives. The clinical examinations were repeated on the same day after the colonoscopy. All abnormal changes in clinical examination results will be assessed by clinical specialists to determine if they are related to laxative intake. Incidence was calculated as the number of subjects with laxative-related adverse events divided by the total number of subjects. | 8 days |
| Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available. |
| 37422241 | Derived | Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc. 2023 Dec;98(6):977-986.e14. doi: 10.1016/j.gie.2023.06.070. Epub 2023 Jul 6. |