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HemorrhoidNCT05089500

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

A study testing Endoscopic injection sclerotherapy and Endoscopic Band Ligation in people with Hemorrhoid and Hemorrhoids, run by Renmin Hospital of Wuhan University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hemorrhoid, Hemorrhoids, Hemorrhoids Internal
What is being tested?
Endoscopic injection sclerotherapy and Endoscopic Band Ligation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
2 sitesChina
Study dates
1 Nov 2021to 29 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.;
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Mingkai Chen

    Wuhan, Hubei, 430060

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Endoscopic injection sclerotherapy, Endoscopic Band Ligation
Keywords
Endoscopic injection sclerotherapy, Endoscopic Band Ligation, Hemorrhoids, Hemorrhoid, Soft Endoscopy
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic injection sclerotherapyOther

    Also called EIS

    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.

  • Endoscopic Band LigationOther

    Also called EBL

    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.

Study groups in NCT05089500
Study groupRoleWhat they receive
Endoscopic injection sclerotherapyExperimentalNot described
Receives: Other: Endoscopic injection sclerotherapy
Endoscopic Band LigationExperimentalNot described
Receives: Other: Endoscopic Band Ligation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurernce rate

    After treatment, the recurrence of internal hemorrhoids symptoms

    Measured: 12 months after surgery

Secondary outcomes (7)

  1. Postoperative complications and adverse events

    Patients from complications and adverse events following intervention (postoperative bleeding, anal distension, pain, urinary retention and others)

    Measured: Postoperative and follow-up periods

  2. early symptom relief rates

    self-rated improvement postoperative 2 weeks and 3 months

    Measured: 2 weeks and 3 months after surgery

  3. HDSS

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

    Measured: 2 week, 3 month, 12 month after surgery

  4. EQ-5D-5L

    the European Quality of Life 5-Dimensions 5-Levels questionnaire, scale -1 ~ 1, high scores means better outcome

    Measured: 2 week, 3 month, 12 month after surgery

  5. EQ-VAS

    the European Quality of visual analogue scale, scale 0-100, high value means better

    Measured: 2 week, 3 month, 12 month after surgery

  6. Surgical costs

    Cost of treatment

    Measured: After surgery

  7. Patient satisfaction survey

    Patient satisfaction evaluation of the treatment method

    Measured: 3 months or 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion29 Mar 2026
  4. Study completion29 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05089500
Sponsor's protocol ID
WDRY2021-K131
Status last verified
Jun 2026
First submitted
14 Oct 2021
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Elbetti C, Giani I, Novelli E, Fucini C, Martellucci J. The single pile classification: a new tool for the classification of haemorrhoidal disease and the comparison of treatment results. Updates Surg. 2015 Dec;67(4):421-6. doi: 10.1007/s13304-015-0333-0. Epub 2015 Nov 7.

    PubMed 26547759

  • Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.

    PubMed 26327134

  • Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.

    PubMed 2295392

  • Cosman BC. Piles of Money: "Hemorrhoids" Are a Billion-Dollar Industry. Am J Gastroenterol. 2019 May;114(5):716-717. doi: 10.14309/ajg.0000000000000234.

    PubMed 30998519

  • van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, Higuero T, Muris JWM, Breukink SO. European Society of ColoProctology: guideline for haemorrhoidal disease. Colorectal Dis. 2020 Jun;22(6):650-662. doi: 10.1111/codi.14975. Epub 2020 Feb 17.

    PubMed 32067353

  • Higuero T, Abramowitz L, Castinel A, Fathallah N, Hemery P, Laclotte Duhoux C, Pigot F, Pillant-Le Moult H, Senejoux A, Siproudhis L, Staumont G, Suduca JM, Vinson-Bonnet B. Guidelines for the treatment of hemorrhoids (short report). J Visc Surg. 2016 Jun;153(3):213-8. doi: 10.1016/j.jviscsurg.2016.03.004. Epub 2016 May 18.

    PubMed 27209079

  • Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2018 Mar;61(3):284-292. doi: 10.1097/DCR.0000000000001030. No abstract available.

    PubMed 29420423

  • Awad AE, Soliman HH, Saif SA, Darwish AM, Mosaad S, Elfert AA. A prospective randomised comparative study of endoscopic band ligation versus injection sclerotherapy of bleeding internal haemorrhoids in patients with liver cirrhosis. Arab J Gastroenterol. 2012 Jun;13(2):77-81. doi: 10.1016/j.ajg.2012.03.008. Epub 2012 Apr 24.

    PubMed 22980596

  • Rubbini M, Ascanelli S. Classification and guidelines of hemorrhoidal disease: Present and future. World J Gastrointest Surg. 2019 Mar 27;11(3):117-121. doi: 10.4240/wjgs.v11.i3.117.

    PubMed 31057696

  • Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.

    PubMed 30451751

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic injection sclerotherapy and Endoscopic Band Ligation in people with Hemorrhoid and Hemorrhoids, run by Renmin Hospital of Wuhan University at 2 sites 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

recurernce rate (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089500, which also lists 10 linked publications.

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 15 Jun 2026.

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