Low-risk colorectal adenoma
Conditions
Interventions
Test group:Clinical intervention basic treatment, health education + ginseng white art granules
Control group:Only clinical intervention for basic treatment and health education
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The following criteria must all be met to be included in the trial: (1) Meet the diagnostic criteria for low-risk colorectal adenoma; This study includes patients with colorectal adenomas who meet the diagnostic criteria outlined in "Integrative Colorectal Oncology" and are classified as low-risk adenomas according to the "Consensus Update of the Multi-Society Task Force on Colorectal Cancer on Surveillance After Colonoscopy and Polypectomy" (i.e., not exhibiting any of the following: 1) longest diameter =10 mm; 2) number =3; 3) tubulovillous/villous histology; 4) concomitant high-grade dysplasia). (2) Undergo colonoscopy (with adequate bowel preparation, reaching the cecum, and a withdrawal time of more than 6 minutes) and have received endoscopic minimally invasive polyp removal; (3) Within 3 months after adenoma removal; (4) Aged 18-70 years, any gender; (5) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: All of the following criteria must be met before they can be included in the test: (1) Patients with adenomas that have not been completely removed; (2) Those who take aspirin, folic acid, calcium, vitamin D and other drugs for a long time; (3) Patients with hereditary polyp diseases such as familial colorectal adenoma polyp disease and hereditary non-polyptic colorectal cancer; (4) Enteroscopy is highly suggestive for patients with inflammatory bowel disease; (5) Those who have suffered from malignant tumors in the past five years; (6) Pregnant and lactating women, or patients who are likely to become pregnant and plan to become pregnant; (7) Severe heart and cerebrovascular diseases, liver and kidney failure, diabetics; (8) Those who have serious mental illness and cannot cooperate with enteroscopy; (9) At present, there are events where it is impossible to study drugs orally (such as difficulty swallowing, chronic diarrhea, intestinal obstruction, etc.); (10) Have participated in or are participating in other clinical researchers in the past 3 months; (11) Researchers believe that there are any other people who are not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of heterogeneous low-risk adenoma: the ratio of the number of cases of recurrence/recurrent colorectal low-risk adenoma within 3 years of the first use of the drug to the total number of cases in this group; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM certificate waiting score (follow-up 1, 5, unplanned follow-up, early withdrawal);The rate of colorectal adenoma worsening: the level and number of confirmed colorectal adenoma deterioration (high-risk adenoma and cancer) within 3 years of the first drug use in this group of patients; | — |
Countries
China
Contacts
Public ContactLi Xiaobo
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed