Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

Shenzhen Hospital of Southern Medical University

Status: Not yet enrolling

Conditions: Internal Hemorrhoid

Treatments: Device: Tie up device

Study type: Observational

Funder types: Other

Identifiers

NCT06250140

ShenzhenH

Details and patient eligibility

About

2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids

2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥18 years old, both sexes

  2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids

  3. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed

Exclusion criteria

• 1. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III

Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.

2. Patients with a history of allergy to narcotic drugs

3. Patients who were deemed by the investigator to be ineligible for participation in the trial

Trial design

900 participants in 3 patient groups

Internal hemorrhoid ligation group

Description:

Endoscopic internal hemorrhoid ligation

Treatment:

Device: Tie up device

Hemorrhoids injection group

Description:

Endoscopic hemorrhoid injection was performed

Treatment:

Device: Tie up device

Internal hemorrhoids combined treatment group

Description:

Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection

Treatment:

Device: Tie up device