UMIN ID: UMIN000002191
Registered date:13/07/2009
A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | large superficial colorectal neoplasms |
Date of first enrollment | 2009/07/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 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 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. |
Outcome(s)
Primary Outcome | The rate of en-bloc resection. The mean operation time. The score of abdominal distension and pain immediately and 1 hour after the procedure. |
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Secondary Outcome | 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. |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | Jichi Medical University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Fuji Film Corporation |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | |
s2k@jichi.ac.jp | |
Affiliation | Jichi Medical University Endoscopy center |
scientific contact | |
Name | Tomohiko Miyata |
Address | 3311-1, yakushiji, shimotuke-shi, tochigi pref. Japan Japan |
Telephone | |
Affiliation | Jichi Medical University Endoscopy center |