An observational study in Frailty in Adult Surgery, Frailty Syndrome and Elective Surgeries, sponsored by University of Iceland. Recruiting at 1 site in Iceland. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by University of Iceland · Observational
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 250 is above the median of 225 across 493 observational studies indexed under Frailty.
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he study population will consist of all patients ≥70 years who have present for preoperative assessment at the admissions department at Landspitali before undergoing major surgery, University Hospital of Iceland.
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Exclusion Criteria:
Patients ≥ 70 years undergoing major elective surgery who are triaged to present for preoperative assessment at the admissions department at Landspitali University Hospital in Iceland. Patients who screen positive on the mEFT (≥3 points) will be considered frail. Those who do not screen positive (≤2 points) will be part of the control group (non-frail).
Procedure: Major elective surgery
Any major elective surgery at Landspítali University Hospital
90-day Readmission
Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. Readmissions to the same hospital on the same day for the same principal diagnosis are not counted in the outcome.
Time frame: From the day of surgery to postoperative day 90.
Surgical Complications
Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
Time frame: From the same day after surgery to postoperative day 30.
Prolonged length of hospital stay
Prolonged length of hospital stay will be defined as an index hospitalization lasting 10 days or longer following the surgical procedure. Length of stay will be calculated as the number of days from the day of surgery to discharge.
Time frame: Postoperative day 0 through discharge from the index hospitalization (up to 180 days).
180-day mortality
Defined as the death of the patient after surgery
Time frame: Up to 180 days after the primary surgery
Non-home discharge
Non-home discharge will be identified as the postoperative hospital discharge to a nursing home or a rehabilitation center. Discharge to patient hotels will not be included. In addition, non-home discharge will not include patients who live in a nursing home prior to the surgery.
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.
Plan to share: No — The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
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University of Iceland