Skip to content

Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study

Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06794151
Enrollment
548
Registered
2025-01-27
Start date
2025-01-01
Completion date
2027-11-30
Last updated
2025-01-27

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

Conditions

Hemorrhoid

Brief summary

This study adopted a multicenter, non-randomized controlled clinical research design. Patients with internal hemorrhoids who met the inclusion criteria were assigned to the endoscopic rubber band ligation group (observation group) or the Milligan-Morgan hemorrhoidectomy group (control group) according to their treatment preferences. Doctors who were unaware of the clinical data information evaluated the patients' postoperative recovery, the occurrence of complications, and the long-term follow-up of treatment efficacy through outpatient reexaminations, WeChat video calls, or telephone calls. Research Subjects and Inclusion/Exclusion Criteria 1.1 Research Subjects Patients with grade II-III internal hemorrhoids 1.2 Inclusion Criteria 1. Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification; 2. Aged between 18 and 80 years old, both males and females; 3. Those who did not respond well to conservative treatments such as dietary adjustments and medications; 4. Patients who signed the informed consent form and were willing to cooperate with this study. 1.3 Exclusion Criteria 1. Patients with contraindications to colonoscopy; 2. Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery; 3. Pregnant patients; 4. Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies; 5. Patients with severe heart, liver, or kidney diseases and coagulation disorders; 6. Patients with diabetes mellitus and poor blood glucose control; 7. Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders; 8. Patients who refused to participate in the study. 1.4 Observation Indicators Primary Indicator: Efficacy Rate Secondary Indicators: Pain, a feeling of fullness and discomfort in the anus, urinary retention, defecation status, long-term therapeutic effect, treatment cost, etc.

Interventions

None listed

Sponsors

Weidong Tong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* (1) Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification; (2) Aged between 18 and 80 years old, both males and females; (3) Those who did not respond well to conservative treatments such as dietary adjustments and medications; (4) Patients who signed the informed consent form and were willing to cooperate with this study.

Exclusion criteria

* (1) Patients with contraindications to colonoscopy; (2) Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery; (3) Pregnant patients; (4) Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies; (5) Patients with severe heart, liver, or kidney diseases and coagulation disorders; (6) Patients with diabetes mellitus and poor blood glucose control; (7) Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders; (8) Patients who refused to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy Rate6 monthsThe primary endpoint of this study is to evaluate the therapeutic effect of hemorrhoids in patients through physical examinations, digital rectal examinations and other means by doctors who are unaware of the clinical data information six months after the operation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026