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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Prolapsed Grade III Internal Haemorrhoid; Grade/Stage I Hemorrhoids; Prolapsed Grade II Internal Haemorrhoid

Treatments: Drug: Sclersing liqiud of Lauromacrogol; Drug: Sclerosing foam of Lauromacrogol

Study type: Interventional

Funder types: Other

Identifiers

NCT04398823

XH-20-006

Details and patient eligibility

About

"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

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 2 patient groups, including a placebo group

Foam sclerotherapy,FS

Active Comparator group

Description:

Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.

Treatment:

Drug: Sclerosing foam of Lauromacrogol

Liquid sclerotherapy,Ls

Placebo Comparator group

Description:

Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.

Treatment:

Drug: Sclersing liqiud of Lauromacrogol