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NCT Number: NCT05089500

Endoscopic Injection Sclerotherapy Versus Endoscopic Band Ligation 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

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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoid Bleeding Hemorrhoid Pain Hemorrhoid Prolapse Hemorrhoids Hemorrhoids Internal Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mingkai Chen, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 or age> 75;
  • External hemorrhoids or mixed hemorrhoids;
  • degree Ⅳ internal hemorrhoids
  • Unsymptomatic internal hemorrhoids
  • Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection；
  • Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;
  • 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.;
  • Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;
  • Women in pregnancy or puerperium;
  • Hardening agent allergy patients, such as polycininol, etc;
  • Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;
  • The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Treatment and study plan

Endoscopic injection sclerotherapy

Other

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

Endoscopic Band Ligation

Other

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

Primary outcomes

  1. recurernce rate

    Time frame: 12 months after surgery

    After treatment, the recurrence of internal hemorrhoids symptoms

Secondary outcomes

  1. 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)

  2. early symptom relief rates

    Time frame: 2 weeks and 3 months after surgery

    self-rated improvement postoperative 2 weeks and 3 months

  3. HDSS

    Time frame: 2 week, 3 month, 12 month after surgery

    Hemorrhoid Disease Symptom Score， scale 0-20, high score means better

  4. 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

  5. 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

  6. Surgical costs

    Time frame: After surgery

    Cost of treatment

  7. Patient satisfaction survey

    Time frame: 3 months or 12 months after surgery

    Patient satisfaction evaluation of the treatment method

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Central Hospital of Xiaogan
  • Chibi People's Hospital
  • Fuyang Second People's Hospital
  • Hubei Hospital of Traditional Chinese Medicine
  • Jingzhou First People's Hospital
  • Shanxi Provincial Fifth People's Hospital
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
  • The First Affiliated Hospital of Nanchang University
  • Tianyou Hospital Affiliated to Wuhan University of Science and Technology
  • Wuhan Puren Hospital
  • Wuhan University of Science and Technology Affiliated Hanyang Hospital
  • Xiaogan First People's Hospital
  • Yichang Central People's Hospital
  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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