A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

Study Overview
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Brief Summary
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Internal hemorrhoid affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

Official Title
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A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

Conditions
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Grade/Stage I Hemorrhoids, Prolapsed Grade II Internal Haemorrhoid, Prolapsed Grade III Internal Haemorrhoid

Intervention / Treatment
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* Drug: Sclerosing foam of Lauromacrogol
* Drug: Sclersing liqiud of Lauromacrogol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People are willing to sign the informed consent form of this trial. People(aged 18 to 70 years) with clinical symptoms such as bleedingprolapse and so on have been diagnosed with grade I, grade II and grade III internal hemorrhoids by colonic epdoscopy; People can follow short-term (3 month) and long-term (12 month) visit plans; Describe symptoms objectively and actively complete the evaluation scale; No allergic diseases and allergy to sclerosing drugs; Non-lactating and pregnant women: patients without pregnancy plan (including the men) in 1 month after the test; Did not participate in any drug trials (including this trial drug) within 3 months before the trial; People with long-term use of anticoagulant drugs (such as aspirin, clopidogrel, etc.) need to be stopped for 5-7 day Exclusion Criteria: People with severe insufficiency of heart, brain, lung and other organs, leading to inability to tolerate endoscopic treatment; People with drug allergies or abnormal blood coagulation function; People suffering from or combined with digestive tract diseases,such as the colon malignancyulcerative colitis or Crohn's diseaseacute diarrheaacute thrombotic internal hemorrhoids with painanal fistulaanal fissurefecal incontinence Men with history of severe prostate hypertrop; People with any reasons that the researchers believe can not be selected

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foam sclerotherapy,FS<br>Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol. | Drug: Sclerosing foam of Lauromacrogol<br>* Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.<br>|
| Placebo Comparator: Liquid sclerotherapy,Ls<br>Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol. | Drug: Sclersing liqiud of Lauromacrogol<br>* Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. | After 12 months,all the participants will receive the telephone follow-up to record their self-assessment. | 12 months | 
| the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. | after 12 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. | one day after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus. | 1 day | 
| the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. | After 3 months,all the participants will receive the telephone follow-up to record their self-assessment. | 3 months | 
| the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. | one week after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus. | 1 week | 
| the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. | after 3 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoids