ACS-NSQIP Calculator for Liver Surgery

Hepatectomy Clinical Trial

Official title:

Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793933
• Other study ID #: ACS-NSQIP
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hepatectomy
• Liver Surgery
• Outcome After Hepatectomy

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