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Completed

NCT Number: NCT04655651

Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

There is no intervention for both groups.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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