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NCT Number: NCT07452263

Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landspitali University hospital

Reykjavik, Hofudborgarsvaedid, 101, Iceland

Location status: Recruiting

Location contact

Luis Rabelo

CONTACT

[email protected]

8203587

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Major elective surgery

Procedure

Any major elective surgery at Landspítali University Hospital

Primary outcomes

  1. 90-day Readmission

    Time frame: From the day of surgery to postoperative day 90.

    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.

  2. Surgical Complications

    Time frame: From the same day after surgery to postoperative day 30.

    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).

Secondary outcomes

  1. Prolonged length of hospital stay

    Time frame: Postoperative day 0 through discharge from the index hospitalization (up to 180 days).

    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.

  2. 180-day mortality

    Time frame: Up to 180 days after the primary surgery

    Defined as the death of the patient after surgery

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis G Rabelo, MD

CONTACT

[email protected]

+3548203587

Martin I Sigurdsson, MD, PhD

CONTACT

[email protected]

+354-824-8282

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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