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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| Qilu Hospital of Shandong University | OTHER |
| Qianfoshan Hospital | OTHER |
| Yantai Yuhuangding Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation group | Experimental | The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy. |
|
| ERAS group | Active Comparator | The ERAS group patients were treated according to the ERAS pathway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation program | Behavioral | Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative (≤30 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Cardio-pulmonary function and physical capacity | The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function. | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery) |
| Quality of life (QoL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanbing Zhou, MD | The Affiliated Hospital of Qingdao University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41604182 | Derived | Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Liu Q, Zhou Y. Supervised Multimodal Prehabilitation and Clinical Outcomes in Older Patients With Frailty and Gastric Cancer: The GISSG+2201 Randomized Clinical Trial. JAMA Surg. 2026 Mar 1;161(3):223-233. doi: 10.1001/jamasurg.2025.6256. | |
| 37816552 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Jining First People's Hospital | OTHER |
| Weifang Medical University | OTHER |
| Weifang People's Hospital | OTHER |
| Dongying People's Hospital | OTHER |
| Weihai Municipal Hospital | OTHER |
| Weihai Central Hospital | OTHER |
| Rizhao People's Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
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| ERAS protocol | Behavioral | 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. |
|
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. |
| 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 | 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. | Postoperative (≤30 days after surgery) |
| Oncological outcomes | 3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate. | 3 years |
| Derived |
| Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Meng C, Kehlet H, Zhou Y. Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201). BMJ Open. 2023 Oct 10;13(10):e071714. doi: 10.1136/bmjopen-2023-071714. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |