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

Primary Purpose

Hemorrhoid, Hemorrhoids, Hemorrhoids Internal

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Endoscopic injection sclerotherapy

Endoscopic Band Ligation

About this trial

This is an interventional treatment trial for Hemorrhoid focused on measuring Endoscopic injection sclerotherapy, Endoscopic Band Ligation, Hemorrhoids, Hemorrhoid, Soft Endoscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mingkai Chen
Renmin Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Endoscopic injection sclerotherapy

Endoscopic Band Ligation

Arm Description

Outcomes

Primary Outcome Measures

recurernce rate

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

Secondary Outcome Measures

Postoperative complications and adverse events

Patients from complications and serious adverse events following intervention

Surgical costs

Cost of treatment

Health-related QIL score

Assessment of patient quality of life after surgery

Patient satisfaction survey

Patient satisfaction evaluation of the treatment method

Full Information

NCT ID

NCT05089500

First Posted

October 14, 2021

Last Updated

October 21, 2021

Sponsor

Renmin Hospital of Wuhan University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05089500

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Renmin Hospital of Wuhan University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

From November 2021 to July 2022, patients with internal hemorrhoids seeking treatment were enrolled according to the following 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 are as follows: age <18 or> 75; External hemorrhoids or mixed hemorrhoids; Ⅳ degree of hemorrhoid 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; Sclerotic with allergy patient , 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoid, Hemorrhoids, Hemorrhoids Internal, Hemorrhoid Prolapse, Hemorrhoid Bleeding, Hemorrhoid Pain

Keywords

Endoscopic injection sclerotherapy, Endoscopic Band Ligation, Hemorrhoids, Hemorrhoid, Soft Endoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

984 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic injection sclerotherapy

Arm Type

Experimental

Arm Title

Endoscopic Band Ligation

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Endoscopic injection sclerotherapy

Other Intervention Name(s)

EIS

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Endoscopic Band Ligation

Other Intervention Name(s)

EBL

Intervention Description

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.

Primary Outcome Measure Information:

Title

recurernce rate

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Postoperative complications and adverse events

Description

Patients from complications and serious adverse events following intervention

Time Frame

12 months

Title

Surgical costs

Description

Cost of treatment

Time Frame

12 months

Title

Health-related QIL score

Description

Assessment of patient quality of life after surgery

Time Frame

12 months

Title

Patient satisfaction survey

Description

Patient satisfaction evaluation of the treatment method

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingkai Chen, M.D

Phone

0086-13720330580

kaimingchen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingkai Chen, M.D

Organizational Affiliation

Renmin Hospital of Wuhan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mingkai Chen

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Facility Name

Renmin Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingkai Chen, doctor

Phone

13720330580

kaimingchen@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

26547759

Citation

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Results Reference

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Citation

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Citation

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

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