| CTRI Number |
CTRI/2025/10/096093 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Impact of frailty on recovery after surgery: A study of surgical outcomes in Frail patients |
|
Scientific Title of Study
|
A Prospective observational study on the relationship of clinical frality score on post operative outcomes in patients undergoing elective and emergency general surgical procedure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandhithaa V |
| Designation |
MBBS UG Student |
| Affiliation |
SRM MCHRC |
| Address |
G Block
3rd Floor
Department of general surgery
SRMMCH RC
SRM Nagar
Potheri
Kattankulathur
Chengalpattu
Tamil Nadu 603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7904922801 |
| Fax |
|
| Email |
nandhithaav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Athira Gopinathan |
| Designation |
HOD and Associate professor |
| Affiliation |
SRM MCHRC |
| Address |
G Block 3rd floor
Department of general surgery
SRM MCHRC
SRM Nagar
Potheri
Kattankulathur
Chengalpattu
Tamil Nadu 603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677161953 |
| Fax |
|
| Email |
drathirag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NandhithaaV |
| Designation |
MBBS UG Student |
| Affiliation |
SRM MCHRC |
| Address |
G Block
3rd Floor
Department of general surgery
SRMMCH RC
SRM Nagar
Potheri
Kattankulathur
Chengalpattu
Tamil Nadu 603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7904922801 |
| Fax |
|
| Email |
nandhithaav@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre,Chengalpattu,Tamil Nadu-603203,India. |
|
|
Primary Sponsor
|
| Name |
The Indian Council of Medical Research |
| Address |
V.Ramalingaswami Bhawan,Ansari Nagar,New Delhi-110029,India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nandhithaa V |
SRM MCHRC
SRM Nagar
Potheri
Kattankulathur
Chengalpattu
Tamil Nadu 603203
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAthira Gopinathan |
SRM Medical college Hospital and Research centre |
Room no 17 G Block 3rd floor
Department of general surgery
SRM MCHRC
SRM Nagar
Potheri
Kattankulathur
Chengalpattu
Tamil Nadu 603203
India
Kancheepuram
TAMIL NADU |
967716953
drathirag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college Hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients (male and female) above 65 years of age who are undergoing elective general surgical procedure as inpatient(group A).
Patients (male and female) above the age of 65 years who are undergoing emergency general surgical procedure as inpatient (group B).
Those who are assessed by ASA grade.
Patients with reliable care givers. |
|
| ExclusionCriteria |
| Details |
Patients who are undergoing emergency surgery after elective procedure will not be included in group B.
Patients that required reoperation after interventions done in outside hospitals
Those who left against medical advice.
Those referred to other centres for definitive treatment.
Patients undergoing minor outpatient procedures [defined as procedures using local anaesthesia].
Patients without reliable care givers.
Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the frailty score of patients undergoing elective and emergency general surgical procedure with post operative outcome |
Intermediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
30/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study explores the relationship between frailty and postoperative outcomes in elderly patients undergoing general surgical procedures in an Indian hospital setting. Frailty is a clinically recognized condition often associated with aging, characterized by a progressive decline in physiological reserve across multiple organ systems. Although it becomes more common with advancing age, frailty is not an inevitable part of aging, nor is it always progressive. As the elderly population continues to grow, more older adults are undergoing both elective and emergency surgeries. This raises the importance of identifying frailty preoperatively, as several international studies have shown it to be a strong predictor of poor surgical outcomes. However, there is limited data from India on this subject. This single-center prospective observational study aims to evaluate frailty using the Clinical Frailty Scale (CFS) in patients aged 65 years and above and to correlate it with postoperative outcomes assessed using the Clavien-Dindo Classification, a widely accepted grading system for surgical complications. The study will include at least 67 patients and apply appropriate statistical methods to analyze the correlation between frailty and outcomes within the first 30 postoperative days. Inclusion criteria involve elderly inpatients undergoing elective or emergency general surgery with reliable caregivers. Patients undergoing minor outpatient procedures or reoperations from other centers will be excluded. Data will be collected through clinical interviews, caregiver input (when necessary), and hospital records. Statistical analysis will be conducted using IBM SPSS Version 21. Implications: If the findings show a significant association between higher frailty scores and poor postoperative outcomes, this could support the routine use of frailty assessment in preoperative evaluations. Such assessments would help in risk stratification, tailoring treatment plans, and guiding surgical decision-making in elderly patients. It could also allow for better preoperative counselling regarding potential risks, ultimately improving patient care in the geriatric surgical population in India. |