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)
Introduction Gastric cancer (GC) diagnosed in the elderly population has become a serious public health problem worldwide. Given the combined effects of frailty and the consequences of cancer treatment, older individuals with GC are more likely than young patients to suffer from postoperative compli...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-10-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e071714.full |
| _version_ | 1827120460465176576 |
|---|---|
| author | Hao Wang Hongbo Wang Henrik Kehlet Xinjian Wang Yuqi Sun Xiaodong Liu Zequn Li Leping Li Yulong Tian Shougen Cao Wenbin Yu Yinlu Ding Xixun Wang Ying Kong Xizeng Hui Jianjun Qu Quanhong Duan Daogui Yang Huanhu Zhang Shaofei Zhou Cheng Meng Yanbing Zhou |
| author_facet | Hao Wang Hongbo Wang Henrik Kehlet Xinjian Wang Yuqi Sun Xiaodong Liu Zequn Li Leping Li Yulong Tian Shougen Cao Wenbin Yu Yinlu Ding Xixun Wang Ying Kong Xizeng Hui Jianjun Qu Quanhong Duan Daogui Yang Huanhu Zhang Shaofei Zhou Cheng Meng Yanbing Zhou |
| author_sort | Hao Wang |
| collection | DOAJ |
| description | Introduction Gastric cancer (GC) diagnosed in the elderly population has become a serious public health problem worldwide. Given the combined effects of frailty and the consequences of cancer treatment, older individuals with GC are more likely than young patients to suffer from postoperative complications and poor clinical outcomes. Nutrition, functional capacity and psychological state-based multimodal prehabilitation, which is dominated by Enhanced Recovery After Surgery (ERAS) pathway management, has been shown to reduce postoperative complications, promote functional recovery and decrease hospitalisation time in certain malignancies. However, no previous studies have investigated the clinical application of multimodal prehabilitation in frail older patients with GC.Methods and analysis The study is a prospective, multicentre randomised controlled trial in which a total of 368 participants who meet the inclusion criteria will be randomised into either a prehabilitation group or an ERAS group. The prehabilitation group will receive multimodal prehabilitation combined with ERAS at least 2 weeks before the gastrectomy is performed, including physical and respiratory training, nutritional support, and therapy and psychosocial treatment. The ERAS group patients will be treated according to the ERAS pathway. All interventions will be supervised by family members. The primary outcome measures are the incidence and severity of postoperative complications. Secondary outcomes include survival, functional capacity and other short-term postoperative outcomes. Overall, the multimodal prehabilitation protocol may improve functional capacity, reduce the surgical stress response and concomitant systemic inflammation, and potentially modulate the tumour microenvironment to improve short-term and long-term clinical outcomes and patients’ quality of life.Ethics and dissemination All procedures and participating centres of this study were approved by their respective ethics committees (QYFYKYLL 916111920). The final study results will be published separately in peer-reviewed journals.Trial registration number NCT05352802. |
| first_indexed | 2024-03-11T13:31:10Z |
| format | Article |
| id | doaj.art-385eb1de088148d5a2115baef4fc004e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-20T13:37:36Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-385eb1de088148d5a2115baef4fc004e2024-09-12T05:20:11ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2023-071714Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201)Hao Wang0Hongbo Wang1Henrik Kehlet2Xinjian Wang3Yuqi Sun4Xiaodong Liu5Zequn Li6Leping Li7Yulong Tian8Shougen Cao9Wenbin Yu10Yinlu Ding11Xixun Wang12Ying Kong13Xizeng Hui14Jianjun Qu15Quanhong Duan16Daogui Yang17Huanhu Zhang18Shaofei Zhou19Cheng Meng20Yanbing Zhou21Department of General Surgery, Dongying People’s Hospital, Dongying, ChinaDepartment of Gastrointestinal Surgery, People’s Hospital of Jimo District, Qingdao, People`s Republic of China2 Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, DenmarkDepartment of Gastrointestinal Surgery, Weihai Central Hospital, Weihai, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of Gastrointestinal Surgery, Shandong Provincial Hospital, Jinan, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of Gastrointestinal Surgery, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Gastrointestinal Surgery, The Second Hospital of Shandong University, Jinan, ChinaDepartment of Gastrointestinal Surgery, Yantai Yuhuangding Hospital, Yantai, ChinaDepartment of Gastrointestinal Surgery, Jining No.1 People’s Hospital, Jining, ChinaDepartment of General Surgery, Rizhao People’s Hospital, Rizhao, ChinaDepartment of Oncological Surgery, Weifang People’s Hospital, Weifang, ChinaDepartment of Gastrointestinal Surgery, Affiliated Hospital of Weifang Medical University, Weifang, ChinaDepartment of Gastrointestinal Surgery, Liaocheng People’s Hospital, Liaocheng, ChinaDepartment of Gastrointestinal Surgery, Weihai Municipal Hospital, Weihai, ChinaDepartment of Gastrointestinal Surgery, Qingdao Municipal Hospital Group, Qingdao, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of General Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaIntroduction Gastric cancer (GC) diagnosed in the elderly population has become a serious public health problem worldwide. Given the combined effects of frailty and the consequences of cancer treatment, older individuals with GC are more likely than young patients to suffer from postoperative complications and poor clinical outcomes. Nutrition, functional capacity and psychological state-based multimodal prehabilitation, which is dominated by Enhanced Recovery After Surgery (ERAS) pathway management, has been shown to reduce postoperative complications, promote functional recovery and decrease hospitalisation time in certain malignancies. However, no previous studies have investigated the clinical application of multimodal prehabilitation in frail older patients with GC.Methods and analysis The study is a prospective, multicentre randomised controlled trial in which a total of 368 participants who meet the inclusion criteria will be randomised into either a prehabilitation group or an ERAS group. The prehabilitation group will receive multimodal prehabilitation combined with ERAS at least 2 weeks before the gastrectomy is performed, including physical and respiratory training, nutritional support, and therapy and psychosocial treatment. The ERAS group patients will be treated according to the ERAS pathway. All interventions will be supervised by family members. The primary outcome measures are the incidence and severity of postoperative complications. Secondary outcomes include survival, functional capacity and other short-term postoperative outcomes. Overall, the multimodal prehabilitation protocol may improve functional capacity, reduce the surgical stress response and concomitant systemic inflammation, and potentially modulate the tumour microenvironment to improve short-term and long-term clinical outcomes and patients’ quality of life.Ethics and dissemination All procedures and participating centres of this study were approved by their respective ethics committees (QYFYKYLL 916111920). The final study results will be published separately in peer-reviewed journals.Trial registration number NCT05352802.https://bmjopen.bmj.com/content/13/10/e071714.full |
| spellingShingle | Hao Wang Hongbo Wang Henrik Kehlet Xinjian Wang Yuqi Sun Xiaodong Liu Zequn Li Leping Li Yulong Tian Shougen Cao Wenbin Yu Yinlu Ding Xixun Wang Ying Kong Xizeng Hui Jianjun Qu Quanhong Duan Daogui Yang Huanhu Zhang Shaofei Zhou Cheng Meng Yanbing Zhou 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/10/e071714.full |
| work_keys_str_mv | AT haowang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT hongbowang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT henrikkehlet multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT xinjianwang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT yuqisun multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT xiaodongliu multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT zequnli multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT lepingli multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT yulongtian multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT shougencao multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT wenbinyu multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT yinluding multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT xixunwang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT yingkong multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT xizenghui multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT jianjunqu multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT quanhongduan multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT daoguiyang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT huanhuzhang multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT shaofeizhou multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT chengmeng multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 AT yanbingzhou multimodalprehabilitationtoimprovetheclinicaloutcomesoffrailelderlypatientswithgastriccancerastudyprotocolforamulticentrerandomisedcontrolledtrialgissg2201 |