Overview
A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
Status:
Recruiting
Recruiting
Trial end date:
2021-12-31
2021-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 inPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of MedicineCollaborators:
Anhui Provincial Hospital
Changzhi People's Hospital
Ganzhou Fifth pepole's Hospital
Jiangsu Provincial Second Chinese Medicine Hospital
Luoyang Central Hospital
Nanjing PLA General Hospital
Shandong Maternal and Chidl Care Service Center
Shanghai Construction Group Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Anhui Medical University
Tongren Hospital,Shanghai Jiao Tong University School of Medicine
West China Forth University Hospital,Sichuan UniversityTreatments:
Polidocanol
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