UnknownPhase 4

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

China700 participantsStarted 2020-05-15

Plain-language summary

"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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.

Timeframe: 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.

Timeframe: 12 months

Trial details

NCT IDNCT04398823

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

Contact for this trial

Feng Shen

18202159980 shenfeng01@xinhuamed.com.cn

View on ClinicalTrials.gov More Grade/Stage I Hemorrhoids trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.

Timeframe: 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.

Timeframe: 12 months