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A clinical trial to evaluate the usefulness of intraoperative intestinal blood f low assessment using anendoscope for the gastrointestinal tract

Phase 1
Recruiting
Conditions
Colorectal Cancer
Registration Number
JPRN-jRCTs032220010
Lead Sponsor
Matsubara Hisahiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Patients who meet all of the following conditions a re eligible.
(1) Patients undergoing colorectal cancer surgery with gastrointestinal anastomosis
(2) Patients must be 20 years of age or older at the time of consent.
(3) Patients whose major organs are functioning a dequately and who are judged by the investigator to be able to undergo surgery safely.
(4) Patients who have received sufficient explanati ons about participation in this study and have give n written consent of their own free will with suffici ent understanding.

Exclusion Criteria

Patients who meet any of the following conditions are not eligible for the study.
(1) Patients with a history of allergy to ICG or iodin e hypersensitivity
2) Patients with preoperative intestinal obstruction
3) Patients who have received preoperative treatm ent (e.g., anticancer drug therapy, radiotherapy, c olorectal stent)
4) Patients who are scheduled to have two or mor e anastomoses
5) Patients with infection in the abdominal cavity 6) Patients with serious comorbidities (cardiac dis ease, pulmonary disease, autoimmune disease, ble eding tendency, poorly controlled hypertension or diabetes, etc.)
7) Pregnant patients
8) Patients who are considered inappropriate for participation in the study by the principal investig ator or sub-investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Difference in blood flow boundary between ICG m ethod and this method (mm)
Secondary Outcome Measures
NameTimeMethod
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