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

NCT04892615 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2021-05-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xian-Jun Yu

    lead OTHER

Principal Investigators

  • Xianjun F Yu · Fudan University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-01-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892615 on ClinicalTrials.gov