Perioperative Depression, an Observational Cohort Study

January 18, 2025 updated by: Max Bell, Karolinska Institutet

This observational cohort study studies two aspects of perioperative depression.

First, it examines the postoperative morbidity and mortality among patients with preoperative depression.

Secondly, in a subset of patients without signs of preoperative depression, the investigators describe the riskfactors for development of de-novo postoperative depression.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

BACKGROUND With over 300 million surgeries performed yearly, the impact of perioperative morbidity weighs heavily on society[1]. Multiple studies have highlighted cardiac-[1], renal-[2], pulmonary-[3] and neurological complications[4] as well as other compound metrics of outcome.[5] Postoperative complications, if survived, sometimes result in major impact on function and quality of life.[6] Whilst somatic complications after major surgery are being increasingly investigated, the research field has scarce data on psychological outcomes such as postoperative depression. Most studies use specific surgical cohorts. These include studies of meningioma surgery[7] and glioma patients[8]; both with elevated risk of postoperative depression. In contrast, no significant difference in antidepressant use was found after vestibular schwannoma surgery.[9] When comparing spinal surgery to coronary artery bypass grafting, hysterectomy, cholecystectomy, chronic obstructive pulmonary disease, congestive heart failure exacerbation, and uncomplicated vaginal delivery, the former had the highest risk for postoperative depression.[10] Etiology of major depressive disorder (MDD) is poorly understood, and diagnosis is difficult.[11, 12] Many who experience a first episode of MDD will go on to suffer from recurrent episodes.[13, 14] When compared to equally disabling somatic disorders treatment for depression is less prevalent, indicating under-treatment of the condition.[15] Additionally, individuals with MDD are at elevated risk of cardiovascular disease and all cause-mortality.[16]

HYPOTHESIS The investigators hypothesize that surgery is a stressful event, potentially triggering depression. The investigators further hypothesize that in selected high-risk patients, postoperative new-onset depression is more common and potentially avoidable.

METHODS The investigators plan to use perioperative data from the surgical planning tool, Orbit. The Orbit cohort at Karolinska University Hospital in Solna and in Huddinge, two separate large university hospitals includes Swedish personal identity number (PIN), patient demographics, American Society of Anesthesiologists (ASA) physical status classification, type, date and duration of anesthesia and surgery. NOMESCO classification can be used to subgroup surgical procedures into sixteen categories; neuro, endocrine, ophthalmic, ear, nose and throat, oral and maxillofacial, cardiac, vascular, thoracic, breast, gastrointestinal, urologic, gynecologic, obstetric, orthopedic, dermatologic and minor surgery. The Orbit cohort is cross-matched with electronical medical records (EMR) allowing us to characterize the patients in the cohort based on pre- and postoperative ICD-codes (diagnoses, co-morbid conditions) and pre- and postoperative ATC-codes (medications). Hospital length of stay, readmissions and dates of death can also be retrieved from the EMR.

By merging Orbit data with EMR-data as described above it effectively allows us to investigate short- and long-term outcome for patients developing (new-onset) postoperative depression; this can be achieved by removing patients with depression diagnoses (using ICD-codes from the EMR) and/or patients with collected antidepressants (using ATC-codes from the EMR) in the years prior to surgery. What is the short- and long-term mortality for these patients? How do they far in terms of overall morbidity and health care utilization? The investigators can also characterize the short- and long-term outcome for patients with preoperative depression, focusing specifically on the patients excluded in the study two. How do these patients fare in term of risks for mortality, morbidity and health care utilization?

Study Type

Observational

Enrollment (Estimated)

700000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This cohort is fully comprised of adult patients undergoing surgery at Karolinska University Hospital in Solna or in Huddinge

Description

Inclusion Criteria:

*Adult patients (18 years or older) undergoing surgery at Karolinska University Hospital in Solna or in Huddinge

Exclusion Criteria:

*Patients under the age of 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Surgical cohort
Adult patients undergoing surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30/60/90/365-day mortality
Death after index surgery, time frames (see below)
30/60/90/365-day mortality
Days At Home Alive at 30 days after surgery
Time Frame: 30 days

DAH-30 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0). For example, if a patient died on day 2 after their surgery whilst still an inpatient, they would be assigned zero (0) days at home; if a patient was discharged from hospital on Day 6 after surgery but was subsequently re-admitted for 4 days before their second hospital discharge, then they would be assigned a DAH-30 value of 20. If a patient has complications and spends 16 days in hospital, and then is transferred to a nursing facility for rehabilitation, and spend 24 days there before finally being discharged to their own home, they would be assigned a DAH-30 value of zero (0), even though 30-16-24 = -10 because the minimum value of DAH-30 should be zero. If a patient dies within 30 days of surgery, irrespective of whether they have spent some time at home, DAH-30 will be scored as zero (0).

That is, DAH-30 captures the impact of any complications after surgery.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Max Bell, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01664-01 Periopdepr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data, may be shared to researchers that provide a methodological sound proposal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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