Colorectal tumor
Conditions
Interventions
None listed
Sponsors
NTT medical center Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a pretreatment endoscopic diagnosis of colorectal adenoma of 20 mm or more or early-stage colorectal cancer with a suspected depth of submucosal slight invasion. All of the following requirements are met. 1) The patient is between 18 and 80 years of age at the time of registration. 2) PS (ECOG) is either 0 or 1. 3) The most recent blood collection laboratory tests within 30 days prior to study enrolment meet all of the following (no blood transfusion within 14 days prior to the blood collection used for enrolment). 1. hemoglobin > 9 g/dL 2. platelets >100,000/mm3 3. AST and ALT < 100 4. serum creatinine < 2.0 mg/dL 4) It is possible to follow the patient for 30 days after treatment. 5) Written consent to participate in the study has been obtained 6) Have an adult living with them at home and be able to come to the hospital within 2 hours.
Exclusion criteria
Exclusion criteria: 1) Has undergone endoscopic treatment for a lower gastrointestinal lesion within 30 days prior to enrolment. 2) Scheduled endoscopic treatment of lower gastrointestinal lesions within 30 days of enrolment. 3) Women of childbearing potential, pregnant or lactating. 4) Complicated psychiatric symptoms and lack of good understanding of the study. 5) History of myocardial infarction or unstable angina within 3 months. 6) Patients with coagulopathies. 7) With active bacterial and fungal infections (fever above 38.5, complicated by bacterial infectivity on imaging or bacteriological examination). 8) Complicated respiratory disease requiring continuous oxygen administration. 9) On dialysis. 10) Positive COVID-19 antigen test or PCR test, e.g. in advance. No symptoms are required. 11) Complicated by poorly controlled hypertension. 12) Other cases in which participation in the study is deemed unjustified by the physician in charge. 13) Cases with a preoperative endoscopic diagnosis of more than 3/4 circumference or more than 10 cm in length, extension into or proximity to the appendiceal orifice or diverticulum, requiring ESD treatment of the orifice or diverticulum area. 14) Sporadic localized tumors with a background of chronic inflammation such as ulcerative colitis, DALM 15) Local residuals after endoscopic resection, postoperative anastomotic lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Readmission rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of adverse event (posterior hemorrhage, delayed perforation, PECS, others) Risk factor analysis for adverse event and readmission Patient Satisfaction Patient survey: 1) Satisfaction with this day surgery 2) If similar surgery is needed next time, would you prefer day surgery 3) Any problems | — |
Countries
Japan
Contacts
Public ContactYohei Minato
NTT medical center Tokyo Department of Gastrointestinal Endoscopy
Outcome results
None listed