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| Name | Class |
|---|---|
| Shanghai Tong Ren Hospital | OTHER |
| Shanghai Construction Group Hospital | UNKNOWN |
| Shandong Maternal and Chidl Care Service Center | UNKNOWN |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
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"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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sclerosing foam of Lauromacrogol | Drug | Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. | After 12 months,all the participants will receive the telephone follow-up to record their self-assessment. | 12 months |
| the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. | after 12 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. | one day after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Shen | Contact | 18202159980 | shenfeng01@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Leiming Xu | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Yi Zhang | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital,Shangha Jiao Tong University | Recruiting | Shanghai | China |
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| OTHER |
| West China Fourth Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| 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 |
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| Sclersing liqiud of Lauromacrogol | Drug | Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol. |
|
| the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. |
After 3 months,all the participants will receive the telephone follow-up to record their self-assessment. |
| 3 months |
| the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. | one week after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus. | 1 week |
| the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. | after 3 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy. | 3 months |
| Zhenzhong Deng | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Haixia Peng | Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Hui Pan | Shanghai Construction Group Hospital | Principal Investigator |
| Fengyu Gao | Shandong Maternal and Child Health Center affiliated to Shandong University | Principal Investigator |
| Hao Zhang | BaoShan People's Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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