NCT04261231

Brief Summary

The scope of this investigation is to demonstrate that the pUSIS values correlate closely with short term post-operative clinical outcome parameters, thus making this scoring system a good predictor for the patients' postoperative course and may become a helpful instrument for decision making concerning the choice of postoperative surveillance and treatment. The obtained follow up results were subjected to correlation analyzis with the pUSIS values in order to determine their association and if possible to recognize threshold values that may indicate a suitable type/intensity of postoperative surveillance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

February 6, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Duration of postoperative hospital stay

    In-hospital days

    1-60 days

  • Duration if intensive care treatment

    ICU hours

    600 hours

  • Duration of postoperative ventilation

    Ventilation hours

    600 hours

  • Postoperative complications

    thromboembolic, hepato-renal, neorologal, infections

    1-60 days

Secondary Outcomes (1)

  • Subjective wellbeeing

    1-60 days

Interventions

Elective surgery in adults

Eligibility Criteria

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

General surgical patients.

You may qualify if:

  • adult patients (\>18 y) undergoing surgery in general anesthesia

You may not qualify if:

  • emergency cases
  • patients aged \< 18 years
  • pregnant women
  • inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Biro P, Gurman G. Proposal for a surrogate surgical invasiveness score to obtain a 'post hoc' quantification of surgical stress and tissue trauma in the context of postoperative outcome assessments. Br J Anaesth. 2014 May;112(5):951-3. doi: 10.1093/bja/aeu127. No abstract available.

    PMID: 24771798BACKGROUND
  • Biro P, Sermeus L, Jankovic R, Savic N, Onutu AH, Ionescu D, Godoroja D, Gurman G. Basic Features and Clinical Applicability of 'Preliminary Universal Surgical Invasiveness Score' (pUSIS): A Multi-Centre Pilot Study. Turk J Anaesthesiol Reanim. 2017 Feb;45(1):9-15. doi: 10.5152/TJAR.2017.77785. Epub 2017 Feb 1.

    PMID: 28377835BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, OperativeAnesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 7, 2020

Study Start

November 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

No plan to share.

Locations