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| Name | Class |
|---|---|
| Suzhou Touchstone International Medical Science Co.,Ltd. | UNKNOWN |
| Chengdu Anorectal Hospital | UNKNOWN |
| Wuhan University | OTHER |
| Fujian Provincial Hospital |
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TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A( TSTstarr+ group) | Experimental | TSTstarr+ is a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation . |
|
| group B ( PPH group) | Active Comparator | PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSTstarr+ | Procedure | TSTstarr+ : a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation . |
| Measure | Description | Time Frame |
|---|---|---|
| the recurrence rate of the severe prolapsed Hemorrhoids after surgery | 780 patients will be enrolled in one year.All patients will be followed up for one year, and then calculate 1 year recurrence rate between TSTstarr+ group and PPH group | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | 1 year | |
| Intraoperative hemorrhage | 1 year | |
| The weight of specimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Hongcheng, Medicine Doctor | Contact | +86 159158157 76 | linhongcheng@hotmail.com |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Nanhai Hospital of Traditional Chinese Medicine | OTHER |
| Changshu Hospital of Traditional Chinese Medicine | OTHER |
| Xuzhou Central Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Shenyang Anorectal Hospital | OTHER |
| Wulumuqi General Hospital of Lanzhou Military Command | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
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|
| PPH | Procedure | PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. |
|
| 1year |
| The volume of specimens | 1year |
| The number of patients with anal pain after surgery | 2 years |
| The number of patients with fecal urgency after surgery | 2 years |
| The number of patients with stricture of anus after surgery | 2 years |
| The number of patients with hemorrhage after surgery | 2 years |
| The number of patients with retention of urine in the early time after surgery | 2 years |
| The number of patients with edema of the anal margin in the early time after surgery | 2 years |
| The time of returning to normal | 2 years |
| The total cost of hospitalization | 2 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |