Predictors, Risk Factors and Outcome Following Major Surgery

NCT02626546 | Completed

• 1 other identifier: 2015/1128-31/4
• Study Type: observational
• Target: 1,061
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, prospective, observational cohort study. Consecutive patients, operated in six University Hospitals in Sweden will be recruited following major surgical procedure. The length of patient recruitment period will be 12 weeks. The length of follow up will be 360 days . The objectives are to determine the postoperative morbidity (during the hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes and to identify risk factors that may potentially be influenced by any intervention in the future. Amendments:

1. 1.The follow-up of mortality is extended to 3 years of the cohort
2. 2.The mortality of the background population at 30 and 90 Days will be analyzed
3. 3.Validation of the Surgical Outcome Risk Tool in the study cohort and in the background population are planned

Conditions

Surgical Procedure, Unspecified; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  postoperative morbidity survey, Clavien Dindo

  3-10 postoperative days

Secondary Outcomes (1)

• postoperative mortality

  30-360 postoperative days and 3 years

Study Arms (1)

Major surgical procedures

All patients selected to follow up

Procedure: Major surgical procedure

Interventions

Major surgical procedure PROCEDURE

observation of postoperative outcomes

Major surgical procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients who are operated for major surgical procedures during the study period in tertiary hospitals in Sweden.

You may qualify if:

• individuals classified by the American Society of Anesthesiologists Physical Status Classification System (ASA) ≥ 3 AND
• are scheduled for elective or emergency surgical procedure classified as -major OR major/complex by Surgical Outcome Risk Tool (SORT)
• Non eligibility criteria are the following surgical procedures:
• organ transplantation
• immediate trauma
• breast
• ear, nose throat
• central nervous system
• cardiac, vascular, pulmonary,
• face, mouth, salivary, thyroidea
• skin, subcutaneous tissue
• endoscopic gastrointestinal
• lack of Swedish identity number

You may not qualify if:

• patients who refuse the follow up
• patients who are not available for the follow up (living in other countries)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Norrlands University Hospital: collaborator
• Region Örebro County: collaborator
• University Hospital, Linkoeping: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Huddinge, 14186, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigriduar Kalman, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PHD

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: December 10, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

SE (1)