The Impact of Preoperative Nutrition Intervention on Muscle Mass Preserve in Older Adults Undergoing Elective Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-90
SponsorSiriraj Hospital

About this trial

Sarcopenia-the progressive loss of muscle mass and strength-is a major clinical issue, especially in surgical patients with malignancy. It's strongly linked to poor postoperative outcomes like increased complications, longer hospital stays, and higher mortality. Surgical stress (trauma, fasting, immobilization) significantly worsens this muscle catabolism.

Consequently, early identification and targeted preoperative intervention are essential. Preoperative nutrition, part of a prehabilitation program, is a key strategy known to attenuate muscle loss and improve recovery. The Skeletal Muscle Index (SMI) is an objective metric used for risk stratification.

The Siriraj Integrated Preoperative and Prehabilitation Center (SiPAP) uses a multidisciplinary model with nutritional counseling, but lacks routine sarcopenia screening or objective SMI measurement. Therefore, the impact of their specific nutritional interventions on preserving muscle mass remains unevaluated.

Hypothesis: The structured, individualized preoperative nutritional intervention delivered by SiPAP to intraabdominal oncology patients will result in a net preservation or positive change in the Skeletal Muscle Index (SMI) over the preoperative period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 60 years to 90 years

Schedules for elective major surgery and formally enrollment in the Enhanced Recovery After Surgery (ERAS) program at Siriraj Hospital. (At Siriraj Hospital, patients scheduled for pre-specific elective major surgeries are enrolled into the ERAS program as individual hospital protocols for each ERAS module. All patients are informed about the ERAS program by their surgical team.)

Referred to the SiPAP center for prehabilitation based on established ERAS hospital preoperative protocol.

Able to provide written informed consent and willing to undergo all research assessments at both time points.

Disqualifiers

Presence of conditions that interfere with bioelectrical impedance analysis (BIA), including an implanted pacemaker or other non-removable electronic medical devices.

Use of medications or supplements known to acutely or chronically affect muscle mass (e.g. corticosteroids, hormonal therapies) during the study period.

Diagnosed neuromuscular disorders that affect baseline muscle mass and strength

Undergo emergency surgery

Trial population

The patients who enroll to Enchanced Recovery After Surgery (ERAS) program, Siriraj Hospital and referred to the SiPAP program

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Change from Baseline in the skeletal muscle index (SMI) at a day admit to surgery

Skeletal muscle index (SMI) determined by bioelectrical impedance analysis (BIA) and report as a value with units of kilograms per meter squared (kg/m2)

Time frame
From a preoperative clinic consultation (baseline) to a day admit to surgery, up to 3 months

Secondary outcomes

1

Change from Baseline in nutrition status at a day admit to surgery

Nutrition status defined by Patient-Generated Subjective Global Assessment (PG-SGA). The minimum PG-SGA score is 0, while the maximum score is 30. The higher the score, the greater the risk of malnutrition.

Time frame
From a preoperative clinic consultation (baseline) to a day admit to surgery, up to 3 months
2

Change from Baseline in sarcopenia classification at a day admit to surgery

Sarcopenia classification based on the Asian Working Group for Sarcopenia (AWGS) 2019 criteria (Possible Sarcopenia, Sarcopenia, Severe Sarcopenia)

Time frame
From a preoperative clinic consultation (baseline) to a day admit to surgery, up to 3 months
3

Change from Baseline in the body weight at a day admit to surgery

Body weight report as units of kilograms (kg)

Time frame
From a preoperative clinic consultation (baseline) to a day admit to surgery, up to 3 months
4

Change from Baseline in the total calorie intake at a day admit to surgery

Total calorie intake report as units of kcal/day

Time frame
From a preoperative clinic consultation (baseline) to a day admit to surgery, up to 3 months

Other outcomes

Sponsors and contacts

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