Impact of Frailty on Postoperative Complications in Oncosurgery

NCT ID: NCT05721391

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-07-12

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 .

Detailed Description

Patients above 65 years age undergoing major Oncosurgery under general anaesthesia with or without Epidural will included , written informed consent will be obtained from all patients. Age, Heigth , Weigth , polypharmacy , smoking status , history of Diabetes ,Hypertension will be noted. Basic investigation Hb% , Serum Albumin , Serum creatinine will be done. ASA Physical status and Surgical risk will be noted .Patients will be evaluated for Frieds 5 point Frailty Assessment Scale (i) Unintended weigth loss of > 5kg in last one year.(ii) self reported exhaustion, (iii) muscle weakness (grip strength) (iv)slow walking speed,(v) Low physical activity and assigned to either No Frail Group (0 criteria) , Pre-Frail (1-2 positive criteria ), Frail (3-5 positive criteria Group).The assessment will be done in the preoperative anaesthesia clinic and include paper based questionnaire, hand dynamometer to measure muscle strength and walking test .

All patients will receive standard general anaesthesia along with Epidural for Abdomino-pelvic surgeries.Intraoperative monitoring 5 lead ECG, NIBP/IBP , SPO2, ETCO2, CVP(Optional),BIS will be done.After induction of anaesthesia Ultrasonography will be performed with curvilinear probe --- at the midpoint of femur anteriorly to measure Rectus Femoris muscle thickness of Right thigh , three consecutive readings will be measured and average of value noted for all patients.

At the end of surgery patient's neuromuscular block will be reversed and trachea extubated , if any patient requires ventilator support note will be made accordingly. Postoperative patients vitals and Input/Output charting will be done .Postoperative analgesia either epidural analgesia or intravenous opioids according to Institutional protocol will be given .Length of ICU Stay and any major cardiac , respiratory , Renal complications , re-exploration will be noted.

Conditions

Frailty; Postoperative Complications

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Non Frail Group

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

No interventions assigned to this group

Pre Frail Group

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

No interventions assigned to this group

Frail Group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients undergoing major onco-surgey

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Anita Kulkarni

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India

Locations

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute

Delhi, , India

Countries

India

Other Identifiers

RGCI Frailty

Identifier Type: -

Identifier Source: org_study_id