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

Not yet recruiting

• Conditions: Safety Issues
• Interventions: Device: drainage tube was removed on 5th days after surgery.; Device: drainage tube was removed on 7th days after surgery.

• Registration Number: NCT04892615
• Lead Sponsor: Xian-Jun Yu

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-15
• Last Update Submitted: 2021-05-15
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19
• Study Start: 2021-06-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	drainage tube was removed on 5th days after surgery.	The drainage tube was removed on the 5th day after surgery.
Cohort B	drainage tube was removed on 7th days after surgery.	The drainage tube was removed on the 7th day after surgery.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xianjun Fudan Yu; 🇨🇳 Shanghai, Sahnghai, China