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

Not Applicable

• Conditions: large superficial colorectal neoplasms

• Registration Number: JPRN-UMIN000002191
• Lead Sponsor: Jichi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-13
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.