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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Endoscopic injection sclerotherapy
* Other: Endoscopic Band Ligation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic injection sclerotherapy<br> | Other: Endoscopic injection sclerotherapy<br>* 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.<br>* Other names: EIS;|
| Experimental: Endoscopic Band Ligation<br> | Other: Endoscopic Band Ligation<br>* 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.<br>* Other names: EBL;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic injection sclerotherapy, Endoscopic Band Ligation, Hemorrhoids, Hemorrhoid, Soft Endoscopy