Clinical trial NCT06794151: Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study
Official title: Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hemorrhoid
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with grade II-III internal hemorrhoids

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: China
country: China
facility: Daping Hospital
state: chongqin
Study officials:
References: