Prevention for Surgical Site Infection After Pancreatic Resection
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Kochi University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- the incidence of surgical site infection
Study Overview
Brief Summary
This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.
Detailed Description
This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusion of insulin determined by the control algorithm of the artificial pancreas.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing elective pancreatic resection for pancreatic diseases.
Exclusion Criteria
- •weight loss greater than 10% during the previous 6 months
- •sign of distant metastasis
- •respiratory, renal, or heart disease
Arms & Interventions
1
glucose levels were controlled using sliding scale
2
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
Intervention: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) (Device)
Outcomes
Primary Outcomes
the incidence of surgical site infection
Time Frame: 30th postoperative day
Secondary Outcomes
- the incidence of hypoglycemia and cost during the hospitalization(during the hospitalization)