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Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | The drainage tube was removed on the 5th day after surgery. |
| |
| Cohort B | The drainage tube was removed on the 7th day after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drainage tube was removed on 5th days after surgery. | Device | drainage tube was removed on 5th days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative pancreatic fistula and abdominal infection; | 3month | |
| Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification. | 3month |
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Inclusion Criteria:
Exclusion Criteria:
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Prepare for elective pancreatic surgery, including laparoscopic or open pancreaticoduodenectomy and distal pancreaticocaudal body resection;
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianjun F Yu | Contact | 18019112906 | yuxianjun@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Xianjun F Yu | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xianjun Fudan Yu | Shanghai | Sahnghai | China |
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| drainage tube was removed on 7th days after surgery. | Device | drainage tube was removed on 7th days after surgery. |
|