Impact of Frailty on Postoperative Complications in Oncosurgery

Completed

• Conditions: Frailty; Postoperative Complications

• Registration Number: NCT05721391
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-01-28
• Study First Posted: 2023-02-10
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Study Completion: 2023-07-12
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients undergoing major onco-surgey

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study incidence of postoperative complications in frail patients	upto 7 days	Postoperative major complications as myocardial infarction, Respiratory failure, cerebrovascular event, renal failure , re-exploration will be noted and statistically analysed.

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	upto 240 hours.	Time from admission to the PACU to shifting to the ward will be noted in hours.

Trial Locations

Locations (2)

Rajiv Gandhi Cancer Institute; 🇮🇳 Delhi, India

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 New Delhi, Delhi, India