Trial | NCT04398823  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    700
"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
Study Started
May 15
2020
Anticipated
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
May 21
2020

Drug Sclerosing foam of Lauromacrogol

Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.

Drug Sclersing liqiud of Lauromacrogol

Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.

Foam sclerotherapy,FS Active Comparator

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

Liquid sclerotherapy,Ls Placebo Comparator

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

Criteria 

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
No Results Posted