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Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

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ClinicalTrials.gov Identifier: NCT04655651
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
Elderly people often have comorbidities. However, there could be a big difference in their health status. Frailty is considered to be relevant to adverse outcomes. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. Therefore it is important to design a research and help to solve this problem.

Condition or disease Intervention/treatment
Frailty Age Problem Surgery Other: No intervention

Detailed Description:
With an aging population and the improvement of medical technology, the number of elderly patients who need surgery is gradually increasing. Elderly people often have comorbidities, malnutrition, and other conditions leading to an increased risk of anesthesia. What's more, there could be a big difference in the health status of the elderly with the same age. Frailty is considered to be highly prevalent with increasing age and to confer high risk for adverse outcomes. A complete evaluation of elderly patients before surgery may help improve the prognosis. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. In this study, we plan to use a comprehensive preoperative frailty assessment and follow up for 30 days after surgery to explore the effect of preoperative frailty on postoperative complications in the elderly after major surgeries. To better evaluate the postoperative complications, we choose comprehensive complication index (CCI), which integrates all complication of the Clavien-Dindo classification and offers a metric approach to measure morbidity.
Study Design
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Study Type : Observational
Estimated Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries
Actual Study Start Date : December 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Frailty
patients with a FRAIL Scale of 3 to 5
 Other: No intervention
There is no intervention for both groups.
Non-frailty
patients with a FRAIL Scale of 0 to 2
 Other: No intervention
There is no intervention for both groups.


Outcome Measures
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Primary Outcome Measures :
  1. the score of comprehensive complication index(CCI) [ Time Frame: 30 days after surgery ]
    CCI is based on the complication grading by Clavien-Dindo Classification and can be calculated online (https://www.assessurgery.com).


Secondary Outcome Measures :
  1. the incidence of postoperative pulmonary complications(PPCs) [ Time Frame: 30 days after surgery ]
    PPCs are a comprehensive evaluation of pulmonary complications. PPCs conclude respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome (ARDS), tracheobronchitis, pulmonary oedema, exacerbation of pre-existing lung disease, pulmonary embolus and death.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over 65 years old who are scheduled for elective major surgery under general anesthesia in Peking Union Medical College Hospital
Criteria

Inclusion Criteria:

  • Aging at least 65 years old.
  • Scheduled for major surgery in Peking Union Medical College Hospital .
  • Understand and be willing to participate in this research, and can provide written informed consent.

Exclusion Criteria:

  • Underwent major surgery within the last month.
  • Can't complete the scale evaluation because of lower limb disability or severe knee osteoarthritis and other conditions that affect walking or climbing stairs.
  • With mental or neurological disorders and unable to cooperative with investigators.
  • Reject to sign the informed consent.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04655651


Contacts
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Contact: Ruoxi Wang 18810651971 rosie_pumch@163.com
Contact: Li Xu 18612672291 pumchxuli@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Li Xu, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Li Xu Peking Union Medical College Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04655651    
Other Study ID Numbers: 2020.10.26
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This study will include preoperative evaluations of the elderly scheduled for major surgery. If required, the data could be shared to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes