Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
NCT ID: NCT05352802
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
368 participants
INTERVENTIONAL
2022-09-01
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Prehabilitation group
The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.
Multimodal prehabilitation program
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
ERAS 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.
ERAS group
The ERAS group patients were treated according to the ERAS pathway.
ERAS 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.
Interventions
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Multimodal prehabilitation program
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
ERAS 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
85 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Qilu Hospital of Shandong University
OTHER
Qianfoshan Hospital
OTHER
Yantai Yuhuangding Hospital
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
The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Principal Investigators
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Yanbing Zhou, MD
Role: STUDY_DIRECTOR
The Affiliated Hospital of Qingdao University
Locations
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Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China
Countries
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References
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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.
Other Identifiers
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GISSG+2201
Identifier Type: -
Identifier Source: org_study_id