ACS-NSQIP Calculator for Liver Surgery

• Sponsor: Humanitas Clinical and Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03793933
• Collaborator: (none)
• Enrollment: 450
• Actual Duration (Months): 38

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Liver Surgery; Hepatectomy; Outcome After Hepatectomy	Procedure: Liver resection

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jan 1, 2019

Outcome Measures

Primary Outcome Measures

1. ACS-NSQIP calculator's ability [From the date of surgery up to three months from the date of surgery]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Humanitas Clinical and Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matteo Donadon, Assistant Professor of Surgery, Humanitas Clinical and Research Center
• ClinicalTrials.gov Identifier: NCT03793933
• Other Study ID Numbers: ACS-NSQIP
• First Posted: Jan 4, 2019
• Last Update Posted: Jan 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 4, 2019