The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
368
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China
The incidence and severity of postoperative complications
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.
Time frame: Postoperative (≤30 days after surgery)
Cardio-pulmonary function and physical capacity
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
Quality of life (QoL).
QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
Detection of immune and inflammatory indicators
Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
The postoperative other observation parameters
Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.
Time frame: Postoperative (≤30 days after surgery)
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Oncological outcomes
3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
Time frame: 3 years