NCT05089500

Brief 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 patients with different internal hemorrhoid scores

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
984

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

October 14, 2021

Last Update Submit

October 21, 2021

Conditions

HemorrhoidHemorrhoidsHemorrhoids InternalHemorrhoid ProlapseHemorrhoid BleedingHemorrhoid Pain

Keywords

Endoscopic injection sclerotherapyEndoscopic Band LigationHemorrhoidsHemorrhoidSoft Endoscopy

Outcome Measures

Primary Outcomes (1)

  • recurernce rate

    After treatment, the recurrence of internal hemorrhoids symptoms (based on Goligher score and HDSS symptom score)

    12 months

Secondary Outcomes (4)

  • Postoperative complications and adverse events

    12 months

  • Surgical costs

    12 months

  • Health-related QIL score

    12 months

  • Patient satisfaction survey

    12 months

Study Arms (2)

Endoscopic injection sclerotherapy

EXPERIMENTAL
Other: Endoscopic injection sclerotherapy

Endoscopic Band Ligation

EXPERIMENTAL
Other: Endoscopic Band Ligation

Interventions

Endoscopic injection sclerotherapyOTHER

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.

Also known as: EIS
Endoscopic injection sclerotherapy
Endoscopic Band LigationOTHER

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.

Also known as: EBL
Endoscopic Band Ligation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mingkai Chen

Wuhan, Hubei, 430060, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (10)

  • 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.

    PMID: 26547759RESULT

  • 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.

    PMID: 26327134RESULT

  • 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.

    PMID: 2295392RESULT

  • 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.

    PMID: 30998519RESULT

  • 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.

    PMID: 32067353RESULT

  • 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.

    PMID: 27209079RESULT

  • 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.

    PMID: 29420423RESULT

  • 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.

    PMID: 22980596RESULT

  • 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.

    PMID: 31057696RESULT

  • 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.

    PMID: 30451751RESULT

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mingkai Chen, M.D

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingkai Chen, M.D

CONTACT

0086-13720330580kaimingchen@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

July 30, 2023

Study Completion

September 30, 2023

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations

CN(2)