NCT05721391

Brief Summary

Advanced ageing is accompanied by loss of reserve in multiple organ systems leading to increased risk of complications after surgery.Frailty is a functional syndrome involving reduced physiological reserve and 25-56% of all elderly surgical patients are reported to be frail .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

January 28, 2023

Last Update Submit

July 13, 2023

Conditions

FrailtyPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • To study incidence of postoperative complications in frail patients

    Postoperative major complications as myocardial infarction, Respiratory failure, cerebrovascular event, renal failure , re-exploration will be noted and statistically analysed.

    upto 7 days

Secondary Outcomes (1)

  • Length of ICU stay

    upto 240 hours.

Study Arms (3)

Non Frail Group

The patients in no frail group did not have any component of Frailty criteria

Pre Frail Group

The patients in prefrail Group had 1-2 component of Frailty criteria.

Frail Group

The patients in Frail Group had 3-5 component of Frailty criteria.

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 65 years old and above undergoing elective major onco- surgeries .

You may qualify if:

  • Patients undergoing major onco-surgey

You may not qualify if:

  • Patient refusal to participate
  • Age \<65 years.
  • Emergency surgery
  • Pre-existing dementia
  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Rajiv Gandhi Cancer Institute

Delhi, 110085, India

Location

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anita Kulkarni, MD

    Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 10, 2023

Study Start

March 1, 2022

Primary Completion

June 30, 2023

Study Completion

July 12, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

IN(2)