CTRI Number |
CTRI/2023/04/051728 [Registered on: 18/04/2023] Trial Registered Prospectively |
Last Modified On: |
17/07/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Risk of complications after surgery in older population |
Scientific Title of Study
|
Relationship between frailty and incidence of postoperative complications in older patients undergoing urological procedures– A prospective observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sarah Sharma |
Designation |
Post Graduate Student |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Anesthesia, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
Phone |
8360187164 |
Fax |
|
Email |
sarahsharma94@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Georgene Singh |
Designation |
Professor |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Anesthesia, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
Phone |
9443292504 |
Fax |
|
Email |
georgenesingh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Georgene Singh |
Designation |
Professor |
Affiliation |
Christian Medical College, Vellore |
Address |
Department of Anesthesia, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
Phone |
9443292504 |
Fax |
|
Email |
georgenesingh@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Fluid Research Grant |
Address |
Christian Medical College, Vellore, Tamil Nadu 632004 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Sarah Sharma |
Christian Medical College |
Department of Urology, Ranipet Campus, Christian Medical College Vellore TAMIL NADU |
8360187164
sarahsharma94@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutonal Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Patients more than 60 years of age undergoing urological procedures requiring anaesthesia |
|
ExclusionCriteria |
Details |
1. Patients refusing to participate in the study.
2. Recent MI, Pneumonia, CVA, AKI or any other severe Acute event within last 3 months.
3. Any Recent illness requiring hospitalisation within last 3 months.
4. Non-Ambulating Patients.
5. Stage III, IV carcinoma and patients with disseminated disease.
6. Post chemotherapy/radiotherapy patients.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
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. |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |