A Study to Examine the Effectiveness of Perioperative Rehabilitation and Nutritional Therapy During Gastrectomy

UMIN ID: UMIN000054719

Registered date:20/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 2024/06/24
• Target sample size: 74
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): In this study, in addition to standard surgical treatment for gastric cancer, perioperative care, and postoperative follow-up, we will implement nutritional therapy (intake of nutritional supplements) for one month before and after surgery, as well as exercise therapy (strength training using TheraBand) from one month before surgery to one year post-surgery. Nutritional Therapy Nutritional supplements such as Meiji Balance Mini (200kcal/125ml, Meiji Co., Ltd.) and Isocal (200kcal/100ml, Nestle Japan Co., Ltd.) will be used. Before surgery, patients will consume two bottles per day from the time of case registration until the day before surgery. After surgery, patients will consume one bottle per day from day 7 to day 30 post-surgery. These nutritional supplements will be provided in addition to regular meals. The type of supplement will be selected and adjusted by a nutritionist according to the patient's preferences. Exercise Therapy TheraBand will be provided for patients to perform self-directed training at home. A physical therapist will instruct patients on the training menu as shown in the appendix, and patients will perform the exercises at home at least three times a week. There are three types of bands with different contraction abilities, and the physical therapist will set the load and select the appropriate band. Patients will record the details of their training sessions themselves.

Outcome(s)

• Primary Outcome: The skeletal mass index at 6 months post-surgery
• Secondary Outcome: Analysis of body composition, QOL evaluation using SF-8, and nutritional status assessment using blood tests during the intervention period up to one year post-surgery

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients with concurrent active malignant diseases 2. Patients who cannot undergo body composition analysis using Inbody due to internal metal implants 3. Patients who are unable to take oral intake due to the condition of their gastric cancer 4. Patients deemed inappropriate for participation in this study by the attending physician

Related Information

• Primary Sponsor: Teine Keijinkai Hospital
• Source(s) of Monetary Support: none