NCT07262034

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

November 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

November 22, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

PreoperativeSarcopeniaBody Composition Analyzer (BIA)Skeletal Muscle Index (SMI)

Outcome Measures

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)

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • A planned interval of less than 14 days between the initial SiPAP visit and hospital admission for surgery.
  • Alcohol consumption or strenuous exercise within the 12 hours preceding the scheduled BIA measurement.
  • Incomplete data on muscle mass or nutritional assessment at either time point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Integrated Preoperative And Prehabilitation Center : SiPAP

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (7)

  • Chaiwat O, Wongyingsinn M, Muangpaisan W, Chalermsri C, Siriussawakul A, Pramyothin P, Thitisakulchai P, Limpawattana P, Thanakiattiwibun C. A simpler screening tool for sarcopenia in surgical patients. PLoS One. 2021 Sep 23;16(9):e0257672. doi: 10.1371/journal.pone.0257672. eCollection 2021.

    PMID: 34555077BACKGROUND
  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PMID: 32033882BACKGROUND
  • Nitichai N, Angkatavanich J, Somlaw N, Voravud N, Lertbutsayanukul C. Validation of the Scored Patient-Generated Subjective Global Assessment (PG-SGA) in Thai Setting and Association with Nutritional Parameters in Cancer Patients. Asian Pac J Cancer Prev. 2019 Apr 29;20(4):1249-1255. doi: 10.31557/APJCP.2019.20.4.1249.

    PMID: 31030501BACKGROUND
  • Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.

    PMID: 26771786BACKGROUND
  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PMID: 28097305BACKGROUND
  • Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

    PMID: 23052535BACKGROUND
  • Arribas L, Sabate-Llobera A, Domingo MC, Taberna M, Sospedra M, Martin L, Gonzalez-Tampan AR, Pallares N, Mesia R, Baracos VE. Assessing dynamic change in muscle during treatment of patients with cancer: Precision testing standards. Clin Nutr. 2022 May;41(5):1059-1065. doi: 10.1016/j.clnu.2022.03.016. Epub 2022 Mar 11.

    PMID: 35395556BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Assoc. Prof. Mingkwan Wongyingsinn, MD

    Department Of Anesthesiology, Faculty Of Medicine Siriraj Hospital

    STUDY DIRECTOR

Central Study Contacts

Mingkwan Wongyingsinn, MD

CONTACT

Parujee Nakjuy, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 3, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 6, 2026

Record last verified: 2025-12

Locations