NCT04892615

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 114 (estimated)
• Sponsor: Xian-Jun Yu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Safety Issues

Interventions

Type	Name	Description
DEVICE	drainage tube was removed on 5th days after surgery.	drainage tube was removed on 5th days after surgery.
DEVICE	drainage tube was removed on 7th days after surgery.	drainage tube was removed on 7th days after surgery.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-01-30
• Completion: 2024-09-30
• First posted: 2021-05-19
• Last updated: 2021-05-19

Locations

1 site across 1 country: China