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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04892615

Enrollment

114

Registered

2021-05-19

Start date

2021-06-01

Completion date

2024-09-30

Last updated

2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

Brief 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).

Interventions

DEVICEdrainage tube was removed on 5th days after surgery.

drainage tube was removed on 5th days after surgery.

DEVICEdrainage tube was removed on 7th days after surgery.

drainage tube was removed on 7th days after surgery.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	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

Countries

China

Contacts

Primary ContactXianjun F Yu

yuxianjun@fudanpci.org18019112906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026