Frailty Assessment of Patients With Gastrointestinal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03930082|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment|
|Gastrointestinal Disease Frail Elderly Syndrome||Other: Frailty Index Scale|
Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded.
The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty.
The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
- Other: Frailty Index Scale
We will evaluate the frailty with a Frailty Index Scale in elderly patients undergoing gastrointestinal surgery.
- operative time [ Time Frame: 2 year ]From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
- Blood loss [ Time Frame: 2 year ]intraoperative blood loss
- Intraoperative complications [ Time Frame: 2 year ]Including all the complications in the procedure
- postoperative complications [ Time Frame: 2 year ]including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.
- The length of stay in intensive care unit (ICU) [ Time Frame: 2 year ]Time form entry to ICU to return to general ward after the condition is stable.
- The length of hospitalization [ Time Frame: 2 year ]Time from admission to discharge
- Hospital costs [ Time Frame: 2 year ]Cost of diagnosis and treatment during hospitalization
- Readmission rate within 30 days [ Time Frame: 2 year ]The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.
- Mortality within 30 days [ Time Frame: 2 year ]death rate within 30 days after surgery in all patients after operation
- Recurrence-free Survival (RFS) [ Time Frame: 2 year ]RFS is the abbreviation of recurrence-free survival, which refers to the duration from postoperation to tumor recurrence (Only for patients with cancers).
- Overall survival (OS) [ Time Frame: 2 year ]OS is the abbreviation of overall survival , which refers to the duration from postoperation to death of the subjects (Only for patients with cancers).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930082
|Contact: Ziqiang Wang, MD,PHDfirstname.lastname@example.org|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Ziqiang Wang, MD,PHD +8618980602028 email@example.com|
|Principal Investigator: Chaoyang Gu, MD|
|Study Chair:||Ziqiang Wang, MD,PHD||Department of Gastrointestinal Surgery, West China Hospital, Sichuan University|