Endoscopic Injection Sclerotherapy Versus Endoscopic Band Ligation for Grade I-III Internal Hemorrhoids

June 11, 2026 updated by: ChenMingkai, Renmin Hospital of Wuhan University

Prospective Multicenter Clinical Study of Flexible Endoscopic Treatment for Grade I-III Internal Hemorrhoids

This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Continuous recruitment of symptomatic internal hemorrhoid patients who visited the main center and sub centers was conducted using a stratified block randomization method, with a 1:1 random allocation to the endoscopic injection sclerotherapy group and endoscopic band ligation group for intervention. During the perioperative period, demographic characteristics, intraoperative conditions, postoperative complications and surgery related costs, length of hospital stay were recorded, and HDSS, EQ-5D-5L, EQ-VAS scores were recorded. Changes in scores were recorded during telephone follow-up at 2 weeks, 3 months, and 12 months after surgery, as well as whether the patient's symptoms improved, recurred, and satisfaction was assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
984

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430060
        • Mingkai Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18 to 75, men and women;
  2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;
  3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

Exclusion Criteria:

  1. Age <18 or age> 75;
  2. External hemorrhoids or mixed hemorrhoids;
  3. degree Ⅳ internal hemorrhoids
  4. Unsymptomatic internal hemorrhoids
  5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection；
  6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;
  7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;
  8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;
  9. Women in pregnancy or puerperium;
  10. Hardening agent allergy patients, such as polycininol, etc;
  11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;
  12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endoscopic injection sclerotherapy
Other: Endoscopic injection sclerotherapy
Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.
Other Names:
  • EIS
Experimental: Endoscopic Band Ligation
Other: Endoscopic Band Ligation
Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.
Other Names:
  • EBL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
recurernce rate
Time Frame: 12 months after surgery
After treatment, the recurrence of internal hemorrhoids symptoms
12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications and adverse events
Time Frame: Postoperative and follow-up periods
Patients from complications and adverse events following intervention (postoperative bleeding, anal distension, pain, urinary retention and others)
Postoperative and follow-up periods
early symptom relief rates
Time Frame: 2 weeks and 3 months after surgery
self-rated improvement postoperative 2 weeks and 3 months
2 weeks and 3 months after surgery
HDSS
Time Frame: 2 week, 3 month, 12 month after surgery
Hemorrhoid Disease Symptom Score， scale 0-20, high score means better
2 week, 3 month, 12 month after surgery
EQ-5D-5L
Time Frame: 2 week, 3 month, 12 month after surgery
the European Quality of Life 5-Dimensions 5-Levels questionnaire, scale -1 ~ 1, high scores means better outcome
2 week, 3 month, 12 month after surgery
EQ-VAS
Time Frame: 2 week, 3 month, 12 month after surgery
the European Quality of visual analogue scale, scale 0-100, high value means better
2 week, 3 month, 12 month after surgery
Surgical costs
Time Frame: After surgery
Cost of treatment
After surgery
Patient satisfaction survey
Time Frame: 3 months or 12 months after surgery
Patient satisfaction evaluation of the treatment method
3 months or 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renmin Hospital of Wuhan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
Zhejiang University
Hubei Hospital of Traditional Chinese Medicine
Yichang Central People's Hospital
Xiaogan First People's Hospital
Jingzhou First People's Hospital
Wuhan Puren Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Central Hospital of Xiaogan
Chibi People's Hospital
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Fuyang Second People's Hospital
Shanxi Provincial Fifth People's Hospital
Wuhan University of Science and Technology Affiliated Hanyang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mingkai Chen, M.D, Renmin Hospital of Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WDRY2021-K131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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