Frail Elderly, Stomach Neoplasms
Conditions
Keywords
Multimodal prehabilitation, ERAS
Brief summary
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.
Interventions
BEHAVIORALMultimodal prehabilitation program
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
BEHAVIORALERAS protocol
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.
Sponsors
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Qianfoshan Hospital
Yantai Yuhuangding Hospital
Jining First People's Hospital
Weifang Medical University
Weifang People's Hospital
Dongying People's Hospital
Weihai Municipal Hospital
Weihai Central Hospital
Rizhao People's Hospital
Liaocheng People's Hospital
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 65-85 years; 2. Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 3. G8 score ≤14; 4. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma; 5. Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection; 6. Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic); 7. Date of surgery ≥2 weeks from baseline (T0) assessment; 8. Physical conditions could meet the requirements of exercise training, and no severe concomitant disease; 9. All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.
Exclusion criteria
1. Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders; 2. End-stage cardiac insufficiency (LVEF\<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV; 3. Cerebral bleeding or infarction (within 6 months); 4. Patients with recurrent infection diseases or serious concomitant disease; 5. Patients who require synchronous surgery due to other illness; 6. Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation); 7. Patients who are participating in any other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of postoperative complications | Postoperative (≤30 days after surgery) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardio-pulmonary function and physical capacity | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function. |
| Quality of life (QoL). | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | 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. |
| Detection of immune and inflammatory indicators | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations |
| The postoperative other observation parameters | Postoperative (≤30 days after surgery) | 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. |
| Oncological outcomes | 3 years | 3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate. |
Countries
China
Outcome results
None listed