Risk of complications after surgery in older population
- Conditions
- Persons encountering health services in other specified circumstances,
- Registration Number
- CTRI/2023/04/051728
- Lead Sponsor
- Fluid Research Grant
- Brief Summary
Frailty, though not specifically defined, is described as a state of reduced physiological reserves and increased vulnerability to developing dependency and/or mortality when exposed to stressors and a limited ability to compensate and recover from the same.
Surgery and anaesthesia are often a major stressor, and current preoperative evaluation methods still fail to properly estimate the perioperative risk in the elderly. Frailty not only affects mortality rates but is also associated with higher rates of complications and hospitalizations, underlining the threat of lasting physical and cognitive disability following surgery. Frail patients often undergo standard care without appropriate attention or preparation, erroneously expecting the same rate of recovery and functional improvement as their non frail peers. Frailty measurement is essential for guiding patient care, as it may help clinicians decide which interventions will more likely be beneficial and which may be harmful to specific individuals.
There are many tools to measure frailty that consider a variety of factors including physical function, cognition, comorbidities, self-reported state of health and clinical judgment. A few of them being the Physical Frailty Phenotype (PFP), Deficit Accumulation Index (DAI), the Edmonton Frail Scale (EFS), the Johns Hopkins Adjusted Clinical Groups (JHACG) frailty assessment, the modified Frailty Index 11 (mFI 11), the Fried frailty criteria and the Clinical Frailty Scale
Quality of Recovery (QoR) after anaesthesia is an important measure of the early postoperative health status of the patient. The QoR 15 score provides a valid, extensive and efficient evaluation of postoperative quality of recovery.
This study aims to assess frailty in patients ≥60 years of age using a questionnaire incorporating both Fried criteria and Clinical Frailty Scale, either at the preoperative anaesthesia clinic or in the peripheral wards. Further, it aims to identify the relationship between frailty status and postoperative complications and quality of recovery in patients undergoing urological surgeries. This analysis does not include patients with emergency procedures or procedures without anaesthesia contribution or operation. This study will also help us determine whether Frailty assessment should be included in routine preanesthetic workup of elderly. This knowledge will help us to tailor-make the management plan for each patient, including surgical and anaesthetic technique, adequate optimisation prior to surgery and in certain indicated cases even reconsidering non-surgical management so as to provide a better quality of recovery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 300
Patients more than 60 years of age undergoing urological procedures requiring anaesthesia.
- Patients refusing to participate in the study.
- Recent MI, Pneumonia, CVA, AKI or any other severe Acute event within last 3 months.
- Any Recent illness requiring hospitalisation within last 3 months.
- Non-Ambulating Patients.
- Stage III, IV carcinoma and patients with disseminated disease.
- Post chemotherapy/radiotherapy patients.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome of this study will be to find relationship between Frailty, as assessed by Fried’s criteria and Clinical Frailty Scale and postoperative anaesthetic and surgical complications as assessed by Clavien Dindo Classification. Fraility will be assessed 1 day prior to surgery and patient will be followed up post operatively for post operative complications, till discharge. Quality of recovery will be assessed 24 hours after surgery.
- Secondary Outcome Measures
Name Time Method Quality of Recovery as assessed by Modified Aldrete Score and QoR 15 scale. These will be applied 24 hours after surgery. Incidence of post anaesthesia Delirium in Frail patients, assessed by CAM scale 24 hours post-surgery Incidence of new onset cognitive impairment as assessed by a repeat 3-word recall and clock draw test (Mini Cog) 24 hours post-surgery Comparison of Clinical Frailty Scale and Fried’s Criteria. Both applied 1 day before the surgery.
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaSarah SharmaPrincipal investigator8360187164sarahsharma94@gmail.com