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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    700
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 24 January 2021

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

Details
Condition Grade/Stage I Hemorrhoids, Prolapsed Grade II Internal Haemorrhoid, Prolapsed Grade III Internal Haemorrhoid, Grade/Stage I Hemorrhoids, Grade/Stage I Hemorrhoids
Treatment Sclerosing foam of Lauromacrogol, Sclersing liqiud of Lauromacrogol
Clinical Study IdentifierNCT04398823
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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