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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Safety Issues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

The drainage tube was removed on the 5th day after surgery.

drainage tube was removed on 5th days after surgery.

Intervention Type DEVICE

drainage tube was removed on 5th days after surgery.

Cohort B

The drainage tube was removed on the 7th day after surgery.

drainage tube was removed on 7th days after surgery.

Intervention Type DEVICE

drainage tube was removed on 7th days after surgery.

Interventions

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drainage tube was removed on 5th days after surgery.

Intervention Type DEVICE

drainage tube was removed on 7th days after surgery.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No