Liver SurgeryNCT03793933
ACS-NSQIP Calculator for Liver Surgery
An observational study of Liver Surgery and Hepatectomy, run by Humanitas Clinical and Research Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Surgery, Hepatectomy, Outcome After Hepatectomy
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study examined a cohort of consecutive patients that underwent hepatectomy at our institution between November 2015 and July 2018.
Who may be able to join
- Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time
Who cannot join
- Any patient with missing data
About this study
Official title: Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors
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
Read the 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.
- Conditions
- Liver Surgery, Hepatectomy, Outcome After Hepatectomy
- Being tested
- Liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Also called Hepatectomy
Surgery for the liver
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the date of surgery up to three months from the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Nov 2015
- Primary completion1 Jul 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793933
- Sponsor's protocol ID
- ACS-NSQIP
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors
- ClinicalTrials.gov ID
- NCT03793933
- Acronym / sponsor ID
- ACS-NSQIP
- Conditions
- Liver Surgery, Hepatectomy, Outcome After Hepatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study examined a cohort of consecutive patients that underwent hepatectomy at our institution between November 2015 and July 2018.
Key inclusion criteria (1 listed)
- Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time
Key exclusion criteria (1 listed)
- Any patient with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionAlso: HepatectomySurgery for the liver | Procedure or surgery | – |
Primary outcome
ACS-NSQIP calculator's ability
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Surgery and Hepatectomy, run by Humanitas Clinical and Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACS-NSQIP calculator's ability (time frame: From the date of surgery up to three months from the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.