Bowel Preparation Clinical Trial
— FFREOfficial title:
Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
Verified date | April 2017 |
Source | Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study compares the efficacy of bowel preparation between the face-to-face re-education(FFRE group) and normal education (no-FFRE group) in patients.
Status | Completed |
Enrollment | 658 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Outpatients aged 18-80 years undergoing colonoscopy who had provided written informed consent Exclusion Criteria: - history of colorectal surgery - severe colonic stricture or obstructing tumour - dysphagia - compromised swallowing reflex or mental status - significant gastroparesis or gastric outlet obstruction or ileus - known or suspected bowel obstruction or perforation - severe chronic renal failure (creatinine clearance<30 ml/min) - severe congestive heart failure (New York Heart Association class III or IV) - uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg) - toxic colitis or megacolon - dehydration - disturbance of electrolytes - pregnancy or lactation - unable to give informed consent - haemodynamically unstable |
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Willingness to repeat bowel preparation among 2 groups. | The willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire | 5 months | |
Other | Polyp detection rate among 2 groups. | Polyp detection rate was defined as the proportion of patients with at least one polyp. | 5 months | |
Other | Withdrawal time among 2 groups. | Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps. | 5 months | |
Other | Caecal intubation rate among 2 groups. | Caecal intubation rate is defined the proportion of patients with caecal intubation. | 5 months | |
Primary | Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores=6 among 2 groups. | This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 2 groups. | 5 months | |
Secondary | Rate of compliance with instructions among 2 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). | 5 months |
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