JPRN-jRCTs032220010
Recruiting
Phase 1
A clinical trial to evaluate the usefulness of intraoperative intestinal blood f low assessment using an endoscope for the gastrointestinal tract
Matsubara Hisahiro0 sites40 target enrollmentApril 8, 2022
ConditionsColorectal Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Matsubara Hisahiro
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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