? ~ ? degree hemorrhoids
Conditions
Interventions
experimental group:Xiaozhiling injection
Control group:Polydocanol injection
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old; (2) Patients diagnosed as I ~ II degree hemorrhoids according to the guidelines for the diagnosis and treatment of hemorrhoids in China (2020), and whose recurrent bleeding is not effective after conservative treatment; (3) Sign the informed consent form voluntarily and follow the requirements of the scheme.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with external hemorrhoids; (2) Patients who are allergic to Xiaozhiling or any component of Polydocanol; (3) Patients with serious systemic diseases (especially untreated); (4) Patients with acute inflammatory reaction in anal region (anal infection, abscess) or anal fissure; (5) fever state; (6) serious and important organ diseases or autoimmune insufficiency; (7) Chronic inflammatory bowel disease (such as Crohn's disease); (8) Patients who have taken antiplatelet, anticoagulant and other drugs that affect blood coagulation function or are known to be in hypercoagulable state in the past week; (9) Pregnant women, lactating women or those who cannot use contraception during the study period; (10) Persons with a history of mental illness or neurological dysfunction; (11) Other circumstances that the researcher considers unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical effective rate was 6 months after operation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical complete success rate was 6 months after operation.;Short-term health scale for hemorrhoids scores changed from baseline at 1 week 1 month 3 months and 6 months after operation.;The Digital rating scale score changed from baseline on the day of injection 1 week after operation and 1 month after operation.;Changes of Hemorrhage grade of hemorrhoid from baseline at 1 week 1 month 3 months and 6 months after operation.;Changes of Sodergren's hemorrhoid severity score at 1 week 1 month 3 months and 6 months after operation compared with baseline.;Socioeconomic issues (economic cost: total cost of treatment excluding reimbursement);Satisfaction evaluation (patients and researchers);Time cost (rest time: returning to normal life and working hours);Clinical recurrence rate at 1 month 3 months and 6 months after operation.; | — |
Countries
China
Contacts
Public ContactRen Donglin
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed