- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07331038
Postoperative Muscle Loss After Gastrectomy
December 28, 2025 updated by: National Taiwan University Hospital
Longitudinal Assessment of Postoperative Muscle Loss and Nutritional Status After Gastrectomy
Investigating postoperative muscle loss after gastrectomy
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chih-Jun Lai, MD,PhD
- Phone Number: +886965327939
- Email: littlecherrytw@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients undergoing gastrectomy
Description
Inclusion Criteria:
- gastrectomy
Exclusion Criteria:
- unable to follow our order
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
surgical related muscle loss
Time Frame: follow up to postoperative 1 year
|
four limb muscle thickness measurement
|
follow up to postoperative 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 12, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2031
Study Registration Dates
First Submitted
December 28, 2025
First Submitted That Met QC Criteria
December 28, 2025
First Posted (Actual)
January 9, 2026
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
December 28, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202511030RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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