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A multicenter, open-label clinical study on the effectiveness and safety of an electric hemorrhoid ligation device for the treatment of mixed hemorrhoids.

A multicenter, open-label clinical study on the effectiveness and safety of an electric hemorrhoid ligation device for the treatment of mixed hemorrhoids.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106328
Enrollment
Unknown
Registered
2025-07-22
Start date
2024-10-31
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Interventions

experimental group:Intraoperative ligation instruments all use an electric hemorrhoid ligator
control group:Intraoperative ligation instruments all use a manual hemorrhoid ligature device

Sponsors

The First Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for mixed hemorrhoids; 2. Patient's age is between 18 and 65 years old; 3. No obvious anal deformities before surgery; 4. Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of anorectal surgery such as hemorrhoids or rectal prolapse within the past six months; 2. Concurrent benign anal diseases such as anal fissure, anal fistula, or perianal abscess; 3. Diagnosed with inflammatory bowel disease or proctitis; 4. Confirmed to have colorectal tumors; 5. Concurrent with cardiovascular or cerebrovascular diseases, unable to tolerate surgery or may increase surgical risk; 6. Patients with chronic or acute liver or kidney dysfunction; 7. Abnormal coagulation function or currently undergoing anticoagulant therapy; 8. Concurrent diabetes with poor blood sugar control; 9. Female patients who are pregnant or in the menstrual period; 10. Patients with intellectual disabilities or a history of mental illness; 11. Those who have participated in other clinical trials within the last 4 weeks before enrollment.

Design outcomes

Primary

MeasureTime frame
surgical duration;anal pain condition;postoperative sensation of heaviness or fullness;perianal edema condition;defecation bleeding condition;anal stenosis condition;postoperative bowel movement condition;

Countries

China

Contacts

Public ContactChen Zuqing

The First Affiliated Hospital of Fujian University of Traditional Chinese Medicine

623205772@qq.com+86 134 8914 4139

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026