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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03793933
Other study ID # ACS-NSQIP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2015
Est. completion date January 1, 2019

Study information

Verified date January 2019
Source Humanitas Clinical and Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) calculator has been endorsed by the surgeons' community to counsel patients and relatives regarding estimated postoperative complications. However, it does not include organ-specific risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for liver tumors


Description:

This is an observational retrospective study conducted in a tertiary-referral university hospital. An established classification of complications, including post-hepatectomy insufficiency and bile leak, was adopted. The endpoint was the rate of complications, mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date January 1, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time

Exclusion Criteria:

- Any patient with missing data

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Liver resection
Surgery for the liver

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Humanitas Clinical and Research Center

Outcome

Type Measure Description Time frame Safety issue
Primary ACS-NSQIP calculator's ability The primary study endpoint was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay in patients undergoing hepatectomy for liver tumors From the date of surgery up to three months from the date of surgery
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