Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps, Pain
Conditions
Keywords
Colonoscopy, Colorectal cancer, Colorectal adenomas, Pain
Brief summary
Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.
Detailed description
Single blinded randomized controlled trial.
Interventions
Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Sponsors
South-Eastern Norway Regional Health Authority
Maria Sklodowska-Curie National Research Institute of Oncology
Erasmus Medical Center
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for screening or polyp surveillance colonoscopy * Patients accepting sedation on demand
Exclusion criteria
* Demand for sedation/analgesia before the start of the procedure * Previous partial or total colonic resection * Pregnancy * Unwilling/unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during colonoscopy | 1 hour | Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation rate | 1 hour | Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation. |
| Cecal intubation time | 1 hour | The time taken to complete insertion of the colonoscope. |
| Pain during colonoscopy | 30 minutes | Patients will be asked to report pain during colonoscopy to an unblinded study assistant. |
| Polyp detection rate | 1 hour | Detection of any colonic polyp, irrespective of histologic type, during each procedure. |
| Dose of medication | 1 hour | Dose of sedative and analgesic medication needed to complete the colonoscopy. |
| Adenoma detection rate | 1 hour | Detection of adenomas during each colonoscopy procedure |
Countries
Norway, Poland
Outcome results
None listed