HemorrhoidNCT06794151
Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study
An observational study of Hemorrhoid, run by Weidong Tong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoid
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with grade II-III internal hemorrhoids
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
- Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification;
- Aged between 18 and 80 years old, both males and females;
- Those who did not respond well to conservative treatments such as dietary adjustments and medications;
- Patients who signed the informed consent form and were willing to cooperate with this study.
1.3 Exclusion Criteria
- Patients with contraindications to colonoscopy;
- Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery;
- Pregnant patients;
- Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies;
- Patients with severe heart, liver, or kidney diseases and coagulation disorders;
- Patients with diabetes mellitus and poor blood glucose control;
- Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders;
- 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.
- Conditions
- Hemorrhoid
- Medical subject headings
- Hemorrhoids
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weidong Tong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weidong Tong, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794151
- Sponsor's protocol ID
- 20241226
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06794151
- Acronym / sponsor ID
- 20241226
- Conditions
- Hemorrhoid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Weidong TongUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification;
- Aged between 18 and 80 years old, both males and females;
- Those who did not respond well to conservative treatments such as dietary adjustments and medications;
- Patients who signed the informed consent form and were willing to cooperate with this study.
1.3 Exclusion Criteria
- Patients with contraindications to colonoscopy;
- Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery;
- Pregnant patients;
- Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies;
- Patients with severe heart, liver, or kidney diseases and coagulation disorders;
- Patients with diabetes mellitus and poor blood glucose control;
- Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with grade II-III internal hemorrhoids
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy Rate
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoid, run by Weidong Tong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.