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Many patients with portal hypertension require surgical treatment each year,and Hassab's operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to treat portal hypertension. However, the potential benefits remain to be demonstrated in the context of a randomized trial. In this study, 120 patients will randomize equally receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria included: platelet count < 50×109/ml, esophageal and gastric varices revealed, agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux on duplex ultrasound examination, complications, platelet and liver function variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open group | Active Comparator | the patients under go the open esophagogastric devascularization and splenectomy |
|
| laparoscopic group | Experimental | the patients under go the laparoscopic esophagogastric devascularization and splenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open surgical procedure | Procedure | open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence | gastroesophageal varices recurrence rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| operation time | Duration of surgical procedure | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| blood loss during surgical procedure | 1 day | |
| blood transfusion during surgical procedure | 1 day | |
| Number of Participants with Serious and Non-Serious Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, Doctor | Contact | +86-29-87679246 | individualliu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine | Recruiting | Xi'an | 710004 | China |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003949 | Diagnostic Techniques, Surgical |
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| laparoscopic surgical procedure | Procedure | laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients |
|
record all kind of postoperative complications in each patient |
| 4 weeks |
| rebleeding | record rebleeding time in each bleeding patient | 1 day |
| cost of hospitalization | 4 weeks |
| survival | record the time of death and the death reason | 5 years |
| length of hospital stay | 4 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |