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CompletedNCT04261231pUSISoutcomeUpdated Apr 2, 2020

Correlation of the "Preliminary Universal Surgical Invasiveness Score" (pUSIS) With Short Term Post-operative Clinical Outcome Parameters. An Observational Study

An observational study in Outcome Assessment, Health Care, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

a number of 60 day-care as well as 100 in-hospital patients undergoing elective surgery in general anesthesia have been enrolled into this observational study. The recruitment of cases happened randomly on a daily basis according to the available operations in the surgical unit where the main investigator (NN) was performing her/his anesthesiological services. Thus there was no selection of specific surgeries or surgical disciplines.

Inclusion criteria: adult patients (>18 y) undergoing surgery in general anesthesia.

Exclusion criteria: emergency cases, patients aged \< 18 years, pregnant women, inability to give informed consent.

The data acquisition consisted of calculation of the individual pUSIS for the selected cases by end of surgery, and by collecting in the follow up period the following set of short term parameters:

In-hospital patients

  • time duration from end of surgery till discharge from PACU
  • time duration from end of surgery till discharge from IMCU
  • time duration from end of surgery till discharge from ICU
  • time duration from end of surgery till discharge from hospital up to 30 days
  • Occurrence and severity of complications the during hospital stay or up to 30 days according to a predefined list

Day-care patients

  • time duration from end of surgery till discharge from PACU
  • time duration from end of surgery till discharge from hospital
  • Occurrence and severity of complications the during hospital stay according to a predefined list
  • Occurrence of readmission due to complications within a period of 10 days after surgery

The predefined list of complications that could be observed during the follow up period consists of:

  • Occurrence of postoperative pain that needed medical intervention, duration of this state, average severity level (according an ordinal scale with the levels: mild, moderate, severe)
  • Occurrence of hemodynamic instability, duration of this state, average severity level (according an ordinal scale with the levels: mild, moderate, severe)
  • Occurrence of postoperative hemorrhage, quantification in total ml of estimated blood loss
  • Occurrence of respiratory support, duration of this state
  • Occurrence of thrombo-embolic complications
  • Occurrence of hepato-renal complications
  • Occurrence of cerebral/neurological complications
  • Occurrence of infectiological/inflamatory complications
  • Average level of self-assessed subjective wellbeing (according an ordinal scale with the levels: excellent, rather good, moderate, bad, extremely bad)

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.

02

Conditions studied

  • Outcome Assessment, Health Care
03

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

General surgical patients.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • emergency cases
  • patients aged \< 18 years
  • pregnant women
  • inability to give informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • ProcedureSurgery and anesthesia

    Elective surgery in adults

06

What researchers measure

Primary outcomes

  1. Duration of postoperative hospital stay

    In-hospital days

    Time frame: 1-60 days

  2. Duration if intensive care treatment

    ICU hours

    Time frame: 600 hours

  3. Duration of postoperative ventilation

    Ventilation hours

    Time frame: 600 hours

  4. Postoperative complications

    thromboembolic, hepato-renal, neorologal, infections

    Time frame: 1-60 days

Secondary outcomes

  1. Subjective wellbeeing

    Likert scale 1 (excellent) to 5 (exteremely bad)

    Time frame: 1-60 days

07

Study locations

1 site
  • University Hospital Zurich, Institue of Anesthesiology
    Zurich, ZH 8091, Switzerland
08

References and documents

Publications

  • 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. PubMed 24771798 ↗
  • 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. PubMed 28377835 ↗

Individual participant data

Plan to share: No — No plan to share.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04261231
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Feb 7, 2020
Start date
Nov 1, 2019
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Apr 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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