Hemorrhoid
Conditions
Interventions
Experimental group:Using the experimental electric hemorrhoid stapler produced by SURGAID MEDICAL (XIAMEN) CO.,LTD.
Control group:Using the already marketed electric anorectal stapler produced by SURGAID MEDICAL (XIAMEN) CO.,LTD.
Sponsors
Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for mixed hemorrhoids or grades II to IV internal hemorrhoids as stipulated in the "Chinese Guidelines for the Diagnosis and Treatment of Hemorrhoids (2020 Edition)"; 2. Age 18 years or above and 65 years or below, with no gender restrictions; 3. Has surgical indications and is scheduled to undergo Tissue-Selecting Therapy Stapler (TST) surgery; 4. Has no severe liver or kidney dysfunction (ALT and/or AST are less than twice the upper limit of normal; serum creatinine and urea nitrogen are also less than twice the upper limit of normal); 5. BMI ranging from 18 to 30; 6. Has read the informed consent form in detail, fully understood this clinical trial, voluntarily participated in the trial and signed the informed consent form; All of the above conditions must be met simultaneously for inclusion.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women with pregnancy plans within 6 months, and their partners; breastfeeding women; 2. Those with severe heart or lung diseases, or those with other severe conditions; 3. Patients and their guardians cannot understand the requirements of participating in the study; 4. Uncontrolled mental disorders; 5. Clearly allergic to the metals used in the product; 6. Patients who have participated in other clinical trials before signing the informed consent but did not reach the study endpoint time limit or reached the study endpoint time limit but were less than 6 months; 7. Patients with pelvic floor dysfunction; 8. Patients who meet the contraindications of the product; 9. Other situations judged by the researcher as not suitable for inclusion. If any of the above conditions are met, the patient will not be eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effectiveness rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Absorption of Adhesive Screws;Evaluation of Anal Stenosis;Anus Function Score;Evaluation of the in-surgery operational performance of the product;Evaluation of anastomosis effect during surgery; | — |
Countries
China
Contacts
Public ContactYehuang Wang
Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Outcome results
None listed