he Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery

The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial

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).

Inclusion Criteria:

• ECOG 0-2;
• The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
• postoperative drainage tube placement;
• Patients with no obvious contraindication to surgery;
• Expected postoperative survival ≥3 months;

Exclusion Criteria:

• Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
• Suspicion or abdominal bleeding within 5 days after surgery;
• suspected biliary and intestinal fistula within 5 days after operation;
• On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.