The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping

October 21, 2021 updated by: ChenMingkai, Renmin Hospital of Wuhan University

A Prospective Multicenter Clinical Study of a Soft Endoscopic Treatment Protocol for Internal Hemorrhoid at Degree I-Ⅲ.

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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

From November 2021 to July 2022, patients with internal hemorrhoids seeking treatment were enrolled according to the following 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 are as follows:

  1. age <18 or> 75;
  2. External hemorrhoids or mixed hemorrhoids;
  3. Ⅳ degree of hemorrhoid
  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. Sclerotic with allergy patient , 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 Type

Interventional

Enrollment (Anticipated)

984

Phase

  • 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 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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
recurernce rate
Time Frame: 12 months
After treatment, the recurrence of internal hemorrhoids symptoms (based on Goligher score and HDSS symptom score)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications and adverse events
Time Frame: 12 months
Patients from complications and serious adverse events following intervention
12 months
Surgical costs
Time Frame: 12 months
Cost of treatment
12 months
Health-related QIL score
Time Frame: 12 months
Assessment of patient quality of life after surgery
12 months
Patient satisfaction survey
Time Frame: 12 months
Patient satisfaction evaluation of the treatment method
12 months

Collaborators and Investigators

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

Sponsor

Renmin Hospital of Wuhan University

Collaborators

The First Affiliated Hospital of Nanchang University
Zhejiang University
Hubei Hospital of Traditional Chinese Medicine
Yichang Central People's Hospital
Wuhan Puren Hospital
Wuhan Hanyang Hospital
Enshi State Central Hospital
Army Military Medical University Southwestern Hospital
Shanxi Provincial Coal Central Hospital
Wuhan Tianyou Hospital
Xiaogan City Central Hospital
Xiaogan City First People's Hospital
Fuyang City Second People's Hospital
Chibi City People's Hospital

Investigators

  • 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 (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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