A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
NCT ID: NCT04398823
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
700 participants
INTERVENTIONAL
2020-05-15
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Foam sclerotherapy,FS
Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.
Sclerosing foam of Lauromacrogol
Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
Liquid sclerotherapy,Ls
Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.
Sclersing liqiud of Lauromacrogol
Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.
Interventions
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Sclerosing foam of Lauromacrogol
Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
Sclersing liqiud of Lauromacrogol
Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Tongren Hospital,Shanghai Jiao Tong University School of Medicine
UNKNOWN
Shanghai Construction Group Hospital
UNKNOWN
Shandong Maternal and Chidl Care Service Center
UNKNOWN
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
West China Forth University Hospital，Sichuan University
UNKNOWN
The First Hospital of Anhui Medical University
UNKNOWN
The First Affiliated Hospital of Zhengzhou University
OTHER
Jiangsu Provincial Second Chinese Medicine Hospital
UNKNOWN
Anhui Provincial Hospital
OTHER_GOV
Luoyang Central Hospital
OTHER
Ganzhou Fifth pepole's Hospital
UNKNOWN
Changzhi People's Hospital
OTHER
Nanjing PLA General Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Leiming Xu
Role: STUDY_CHAIR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yi Zhang
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhenzhong Deng
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Haixia Peng
Role: PRINCIPAL_INVESTIGATOR
Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine
Hui Pan
Role: PRINCIPAL_INVESTIGATOR
Shanghai Construction Group Hospital
Fengyu Gao
Role: PRINCIPAL_INVESTIGATOR
Shandong Maternal and Child Health Center affiliated to Shandong University
Hao Zhang
Role: PRINCIPAL_INVESTIGATOR
BaoShan People's Hospital
Locations
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Xinhua Hospital,Shangha Jiao Tong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Feng Shen
Role: primary
Other Identifiers
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XH-20-006
Identifier Type: -
Identifier Source: org_study_id
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