NCT04556019RecruitingNot Applicable
Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
Fundacion Miguel Servet1 site in 1 country1,000 target enrollmentStarted: January 3, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit
Study Overview
Brief Summary
The main aims of this study are:
-
- to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit.
-
- to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 15 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients operated by the HPB Surgical Unit in the last 10 years (retrospective)
- •All patients being operated by the HPB Surgical Unit from January 2019 onwards who provide inform consent (prospective).
Exclusion Criteria
- •Patients not eligible for surgery
- •Patients not interested in taking part in the study
Outcomes
Primary Outcomes
Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit
Time Frame: 90 days post-surgery
Morbidity and mortality outcomes are evaluated following the criteria and definitions from Claven-Dindo and ISGPS international classifications
Survival rate of patients operated by the HPB Surgical Unit
Time Frame: 5-years post-surgery
These patients are operated due to tumoral cause
Disease-free survival rate of patients operated by the HPB Surgical Unit
Time Frame: 5-years post-surgery
These patients are operated due to tumoral cause
Secondary Outcomes
- Evaluation of the result of the multimodal treatment(90 days)
- Assessment of standardization of pre and post-surgical care(90 days)
- Assessment of the results from minimally invasive techniques in HPB surgery(90 days)
- Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause(5 years)
Investigators
Study Sites (1)
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