Status:
ACTIVE_NOT_RECRUITING
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Conditions:
Stomach Neoplasms
Frail Elderly
Eligibility:
All Genders
65-85 years
Phase:
NA
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 ga...
Eligibility Criteria
Inclusion
- Aged 65-85 years;
- Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- G8 score ≤14;
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
- Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
- Date of surgery ≥2 weeks from baseline (T0) assessment;
- Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
- 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
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- 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;
- Cerebral bleeding or infarction (within 6 months);
- Patients with recurrent infection diseases or serious concomitant disease;
- Patients who require synchronous surgery due to other illness;
- Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
- Patients who are participating in any other clinical trials.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT05352802
Start Date
September 1 2022
End Date
May 1 2027
Last Update
December 13 2024
Active Locations (1)
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1
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China, 266000