Colorectal Cancer
Conditions
Keywords
Colorectal cancer screening, Optical colonoscopy, Water method, Sedation
Brief summary
Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.
Detailed description
Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy. Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees. Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request. Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy. Limitations: Single VA site, older male population
Interventions
PROCEDUREAir insufflation colonoscopy
Conventional colonoscopy with air insufflation
PROCEDUREColonoscopy for colorectal cancer screening
PROCEDUREWater Infusion Colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy
Sponsors
East Bay Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (\> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy, * Accept randomization to the study or the conventional method, and agree to complete study questionnaires * The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2
Exclusion criteria
* Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded * Excluded patients will be managed by usual procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increments of medications used for sedation | duration of procedure |
Secondary
| Measure | Time frame |
|---|---|
| pain score during colonoscopy | duration of procedure |
| success of cecal intubation | duration of study |
| willingness to repeat colonoscopy | duration of study |
Countries
United States
Outcome results
None listed