Postoperative Muscle Loss After Gastrectomy

NCT ID: NCT07331038

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2031-12-31

Brief Summary

Investigating postoperative muscle loss after gastrectomy

Detailed Description

Surgical-related muscle loss (SRML) is a common postoperative complication, defined as a reduction of at least 10% in preoperative skeletal muscle mass in at least one upper limb and one lower limb by postoperative day 7. Patients undergoing gastric cancer surgery are typically older and at high risk for low muscle mass, and surgical stress further exacerbates the incidence of SRML. In addition to limb skeletal muscles, swallowing-related muscle groups may also be affected, leading to impaired nutritional intake and increased risks of postoperative complications and mortality. In recent years, ultrasonography-owing to its noninvasiveness, bedside feasibility, and repeatability-has been regarded as a practical tool for monitoring postoperative muscle changes. This study aims to longitudinally track changes in skeletal muscle thickness using ultrasound in patients undergoing gastrectomy for gastric cancer, while concurrently assessing nutritional status and clinical recovery, with the goal of establishing an early clinical assessment model for detecting postoperative muscle loss to inform nutritional interventions and postoperative care. Accordingly, this project will conduct a cohort study of 100 patients to investigate postoperative muscle loss and associated risk factors, including swallowing function and postoperative complications. This prospective observational study will enroll patients aged ≥20 years who undergo gastrectomy and provide written informed consent; individuals with psychiatric conditions that may impair consent or study procedures will be excluded. A total of 100 patients undergoing gastric cancer resection will be assessed preoperatively (T0) and at postoperative day 7 ±2 (T1), 1 month ±1 week (T2), 3 months ±2 weeks (T3), 6 months ±2 weeks (T4), and 12 months ±2 weeks (T5). Assessments will include ultrasound-measured muscle thickness, bioelectrical impedance analysis, handgrip strength and limb muscle strength, tongue pressure, life quality and activity associated questionnaire, and blood tests for nutritional, markers. The expected outcome is that patients with lower preoperative muscle mass and those at high risk of malnutrition will be more susceptible to postoperative muscle loss, and the occurrence of postoperative muscle loss will be associated with an increased risk of postoperative complications.

Conditions

Postoperative Muscle Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• gastrectomy

Exclusion Criteria

• unable to follow our order

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chih-Jun Lai, MD,PhD

Role: CONTACT

littlecherrytw@gmail.com

+886965327939

Other Identifiers

202511030RIND

Identifier Type: -

Identifier Source: org_study_id