Status:
UNKNOWN
A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Tongren Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai Construction Group Hospital
Conditions:
Grade/Stage I Hemorrhoids
Prolapsed Grade II Internal Haemorrhoid
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04398823
Start Date
May 15 2020
End Date
December 31 2021
Last Update
May 21 2020
Active Locations (1)
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1
Xinhua Hospital,Shangha Jiao Tong University
Shanghai, China