NCT04663958

Brief Summary

The term postoperative pulmonary complication is the development of any complications affecting the respiratory system after anesthetic and surgery procedures. The ARISCAT risk assessment score is a seven-variable regression model that divides patients into low, moderate, and high-risk groups. In this study, the investigators aimed to investigate the effectiveness of the ARISCAT risk scoring index in predicting postoperative pulmonary complication development in patients scheduled for major abdominal cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

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

First Submitted

Initial submission to the registry

November 24, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

December 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

November 24, 2020

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the ARISCAT risk scoring index

    to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing major abdominal cancer surgery

    postoperative first 7 days

Secondary Outcomes (12)

  • Correlation between age (years) and PPC

    postoperative first 30 days

  • Correlation between gender(male or female) and PPC

    postoperative first 30 days

  • Correlation between BMI (kg/m^2) and PPC

    postoperative first 30 days

  • Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC

    postoperative first 30 days

  • Correlation between ASA physical score (1-4) and PPC

    postoperative first 30 days

  • +7 more secondary outcomes

Interventions

Detection / ScreeningDIAGNOSTIC_TEST

The patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality.

Eligibility Criteria

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

A total of 420 patients operated in General Surgery, Urology, and Gynecological Oncology departments were included in the study. Seven of these patients were excluded from the study because they did not sign the written consent, and three patients were excluded due to a lack of data.

You may qualify if:

  • Over 18 years of age
  • Who were scheduled for general anesthesia
  • Whose ASA physical score was 1-4

You may not qualify if:

  • ASA physical status\> 4
  • Pregnant women
  • Intubated patients before the operation
  • Patients who had surgery due to a previous surgical complication
  • Severe cardiovascular disease
  • Severe hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (7)

  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

    PMID: 21045639BACKGROUND
  • Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

    PMID: 28186222BACKGROUND
  • Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.

    PMID: 11712875BACKGROUND
  • Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.

    PMID: 25930169BACKGROUND
  • Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499.

    PMID: 23287892BACKGROUND
  • Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

    PMID: 25058504BACKGROUND
  • Perilli V, Aceto P, Ancona P, De Cicco R, Papanice D, Magalini S, Pepe G, Cozza V, Gui D, Lai C, Sollazzi L. Role of surgical setting and patients-related factors in predicting the occurrence of postoperative pulmonary complications after abdominal surgery. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2):547-550. doi: 10.26355/eurrev_201801_14208.

    PMID: 29424916BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsNeoplasmsPulmonary AtelectasisPneumonia

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • MUSTAFA KEMAL SAHIN, Dr

    Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 11, 2020

Study Start

December 21, 2020

Primary Completion

June 18, 2021

Study Completion

August 18, 2021

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations