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A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors

Not Applicable
Conditions
colorectal tumor
Registration Number
JPRN-UMIN000038529
Lead Sponsor
Shonan Fujisawa Tokushukai Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

1) Pregnant patients or with the possibility of the pregnancy 2) Lactating patients 3) Patients disqualified for this study by the physician 4) Patients who have participated in this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dissection speed
Secondary Outcome Measures
NameTimeMethod
Total volume of injection solution used during the ESD procedure; perforation rate; Frequency of the intraoperative bleeding that requires hemostatic forceps; Post-ESD bleeding rate; Post-ESD coagulation syndrome rate; Variation in white blood cell count, blood CRP level, and blood Na level on the day of and the day after the ESD procedure; Time required to create the mucosal flap; Frequency of UESD interruptions due to bleeding; Time required to return to UESD post-UESD interruption due to bleeding; Frequency of CESD interruptions due to bleeding; Time required to return to CESD post-CESD interruption due to bleeding; Dissection speed according to the lesion location; ESD procedure time according to the lesion location; Dissection speed according to the presence of fibrosis; ESD procedure time according to the presence of fibrosis; Dissection speed according to the positional relationship with gravity; Time for the ESD procedure according to the positional relationship with gravity
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