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Recruiting NCT07452263

Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery

Observational Frailty in Adult Surgery Frailty Syndrome Elective Surgeries Readmission Rates

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Major elective surgery.
Who it may be relevant to
Registry conditions: Frailty in Adult Surgery, Frailty Syndrome, Elective Surgeries, Readmission Rates. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iceland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery

Overview

Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists. The Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study. We therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI \<22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g/L for men and 120 g/L for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution. This study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.

Interventions

  • Procedure Major elective surgery
    Any major elective surgery at Landspítali University Hospital

Primary outcome measures

  • 90-day Readmission [Time frame: From the day of surgery to postoperative day 90.]
  • Surgical Complications [Time frame: From the same day after surgery to postoperative day 30.]
Secondary outcome measures (3)
  • Prolonged length of hospital stay [Time frame: Postoperative day 0 through discharge from the index hospitalization (up to 180 days).]
  • 180-day mortality [Time frame: Up to 180 days after the primary surgery]
  • Non-home discharge [Time frame: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.]

Eligibility criteria

Inclusion criteria

  • Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.
  • Patients assigned to undergo major surgery

Exclusion criteria

  • Cardiac surgery
  • Not undergoing planned surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Iceland · 1 center
  • Landspitali University hospital — Reykjavik

Publications

  • Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9. PMID 36307919

Identifiers

NCT: NCT07452263 · UI-Frailty-VRN25/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗