large superficial colorectal neoplasms
Conditions
Interventions
To assess the influence of the air insufflation to the success rate of colorectal ESD and the patient'
s discomfort during the procedure, and the association of harmful events. The study period will be from approval until 31 March 2010.
To assess the influence of the carbon dioxide insufflation to the
s discomfort during the procedure, and the association of harmful events. The study period will be from approval until 31 March 2010.
Sponsors
Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with superficial colorectal tumor larger than 2cm.
Exclusion criteria
Exclusion criteria: Patients for whom colorectal tumor resection cannot be expected to improve survival prognosis due to serious underlying disease (advanced cancer, severe infection, serious respiratory disease or cardiovascular disease) Patients who are under age or have dementia, or who cannot grant informed consent themselves for some other comparable reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of en-bloc resection. The mean operation time. The score of abdominal distension and pain immediately and 1 hour after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of complication. The amount of sedative administered during the procedure. The amounts of gas in the intestine, immediately and 1 hour after the procedure. difference of the abdominal circumference before and immediately after the procedure. | — |
Countries
Japan
Outcome results
None listed