NCT06794151

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. 1.Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification;
  2. 2.Aged between 18 and 80 years old, both males and females;
  3. 3.Those who did not respond well to conservative treatments such as dietary adjustments and medications;
  4. 4.Patients who signed the informed consent form and were willing to cooperate with this study.
  5. 5.Patients with contraindications to colonoscopy;
  6. 6.Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery;
  7. 7.Pregnant patients;
  8. 8.Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies;
  9. 9.Patients with severe heart, liver, or kidney diseases and coagulation disorders;
  10. 10.Patients with diabetes mellitus and poor blood glucose control;
  11. 11.Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders;
  12. 12.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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2025Nov 2027

Study Start

First participant enrolled

January 1, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

Hemorrhoid

Outcome Measures

Primary Outcomes (1)

  • Efficacy Rate

    The 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.

    6 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with grade II-III internal hemorrhoids

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital

China, Chongqin, 400042, China

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI 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 Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

CN(1)