Clinical trial NCT04398823: A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
Official title: A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Grade/Stage I Hemorrhoids
Prolapsed Grade II Internal Haemorrhoid
Prolapsed Grade III Internal Haemorrhoid
Keywords: hemorrhoids
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Tongren Hospital,Shanghai Jiao Tong University School of Medicine
name: Shanghai Construction Group Hospital
name: Shandong Maternal and Chidl Care Service Center
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: West China Forth University Hospital，Sichuan University
name: The First Hospital of Anhui Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Jiangsu Provincial Second Chinese Medicine Hospital
name: Anhui Provincial Hospital
name: Luoyang Central Hospital
name: Ganzhou Fifth pepole's Hospital
name: Changzhi People's Hospital
name: Nanjing PLA General Hospital
First posted: 2020-05-21
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility 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

Primary outcomes:
measure: the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
timeFrame: 12 months
measure: the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
timeFrame: 12 months
Secondary outcomes:
measure: the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
timeFrame: 1 day
measure: the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
timeFrame: 3 months
measure: the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
timeFrame: 1 week
measure: the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital,Shangha Jiao Tong University
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Leiming Xu
role: STUDY_CHAIR
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yi Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhenzhong Deng
role: PRINCIPAL_INVESTIGATOR
affiliation: Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine
name: Haixia Peng
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Construction Group Hospital
name: Hui Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Maternal and Child Health Center affiliated to Shandong University
name: Fengyu Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: BaoShan People's Hospital
name: Hao Zhang
role: PRINCIPAL_INVESTIGATOR
References: