NCT03793933

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

January 3, 2019

Last Update Submit

January 3, 2019

Conditions

Liver SurgeryHepatectomyOutcome After Hepatectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Liver resectionPROCEDURE

Surgery for the liver

Also known as: Hepatectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study examined a cohort of consecutive patients that underwent hepatectomy at our institution between November 2015 and July 2018.

You may qualify if:

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

You may not qualify if:

  • Any patient with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 4, 2019

Study Start

November 1, 2015

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share