Active — Not RecruitingNot Applicable

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

China548 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy Rate

Timeframe: 6 months

Trial details

NCT IDNCT06794151

SponsorWeidong Tong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11-30

View on ClinicalTrials.gov More Hemorrhoid trials