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

Xian-Jun Yu

Status

Not yet enrolling

Conditions

Safety Issues

Treatments

Device: drainage tube was removed on 7th days after surgery.

Device: drainage tube was removed on 5th days after surgery.

Study type

Observational

Funder types

Other

Identifiers

NCT04892615

CSPAC-34

Details and patient eligibility

About

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).

Enrollment

114 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.