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The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection.
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost. A history of colorectal resection represents an independent predictor for inadequate colon cleansing,hence strategies to improve bowel preparation may be a demanding goal in this subset of patients.
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L polyethylene glycol electrolyte solution) and high-volume preparation (4L polyethylene glycol electrolyte solution, 4L PEG-ELS) in patients with previous colorectal resection. Then the investigators can select the optimized regimen for patients with colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GroupA：standard preparation | Active Comparator | Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure. |
|
| Group B:low-volume preparation | Experimental | Subjects who are randomized into group B receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. ( 2L PEG-ELS and 10mg bisacodyl ) |
|
| Group C：high-volume preparation | Experimental | Subjects who are randomized into group C will receive 2L PEG-ELS at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure. (4 L PEG-ELS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard preparation (2L PEG-ELS) | Drug | Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of scores rating by Aronchick Preparation Scale among 3 groups. | This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of compliance with instructions among 3 groups | Compliance was scored on a 3-grade scale based on the intake of bowel solution: 0 = optimal (intake of 100% of the solution); 1 = good (intake of ≥75% of the solution); 2 = poor (intake of <75% of the solution). | 6 months |
| Willingness to repeat bowel preparation among 3 groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li yanqing, PhD,MD | Contact | 86-531-82169236 | 82169508 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| li yanqing, PhD,MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D012015 | Reference Standards |
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
| D003408 | Cresols |
| D010636 | Phenols |
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| low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) | Drug | Subjects who are randomized into group B will receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. |
|
| high-volume preparation (4L PEG-ELS) | Drug | Subjects who are randomized into group C will receive 2L PEG at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure.(4L PEG) |
|
the willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire |
| 6 months |
| Polyp detection rate among 3 groups. | Polyp detection rate was defined as the proportion of patients with at least one polyp. | 6 months |
| Withdrawal time among 3 groups. | Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps. | 6 months |
| Caecal intubation rate among 3 groups. | Caecal intubation rate is defined the proportion of patients with caecal intubation. | 6 months |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |