CTRI

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CTRI Number

CTRI/2025/09/094897 [Registered on: 16/09/2025] Trial Registered Prospectively

Last Modified On:

12/09/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Prospective Observational Study on Frailty and Postoperative Recovery

Study Design

Single Arm Study

Public Title of Study

Study on How Frailty Affects Recovery After Surgery in Older Adults

Scientific Title of Study

ROLE OF FRAILITY IN PREDICTING POSTOPERATIVE RECOVERY: IN GERIATRIC SURGERY USING EDMONTON FRAIL SCALE AND BARTHEL INDEX - AN OBSERVATIONAL STUDY

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr NARENDRA BABU M C
Designation	PROFESSOR
Affiliation	Sapthagiri Institute Of Medical Sciences And Research Centre
Address	Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Bangalore KARNATAKA 560090 India
Phone	9900214064
Fax
Email	narendrababuchanappa@gmail.com

Details of Contact Person
Scientific Query

Name	Dr NARENDRA BABU M C
Designation	PROFESSOR
Affiliation	Sapthagiri Institute Of Medical Sciences And Research Centre
Address	Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Bangalore KARNATAKA 560090 India
Phone	9900214064
Fax
Email	narendrababuchanappa@gmail.com

Details of Contact Person
Public Query

Name	ASMA KALEEM PASHA
Designation	junior resident
Affiliation	Sapthagiri Institute Of Medical Sciences And Research Centre
Address	Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Bangalore KARNATAKA 560090 India
Phone	08095353750
Fax
Email	asmakp27@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Sapthagiri Institute of Medical Sciences and Research Centre
Address	15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
ASMA KALEEM PASHA	Sapthagiri Institute of Medical Sciences and Research Centre	Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka – 560090, India Bangalore KARNATAKA	08095353750 asmakp27@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee , Sapthagiri Institute of Medical Sciences and Research Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: R54\|\|Age-related physical debility,

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	1 Patients aged 60 years or older 2 Scheduled for elective general, orthopedic, or urologic surgery 3 Able to provide informed consent 4 Ambulatory and conscious at the time of preoperative assessment.

ExclusionCriteria

Details

1 Emergency surgeries
2 Patients with terminal illness
3 Patients with severe cognitive dysfunction or communication difficulties preventing assessment
4 ICU-admitted patients preoperatively

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Association between preoperative frailty (Edmonton Frail Scale) and postoperative functional recovery (Barthel Index).	At baseline (preoperative), and at post-operative day 5 or at the time of hospital discharge (whichever occurs earlier)

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="22"
Sample Size from India="22"
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)

23/09/2025

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="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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 observational study is being conducted in a tertiary care center to evaluate the role of frailty in predicting postoperative recovery among geriatric surgical patients. Frailty is assessed preoperatively using the Edmonton Frail Scale. Functional recovery is assessed postoperatively using the Barthel Index. The primary objective is to study the association between preoperative frailty and postoperative recovery. The study will include approximately 22 patients above the age of 60 years undergoing elective or emergency surgery. Patients will be followed up until discharge and/or at 5 days postoperatively. Findings from this study may help to identify frail elderly patients at higher risk of poor recovery and guide perioperative planning and optimization.