Clinical trial NCT05721391: Impact of Frailty on Postoperative Complications in Oncosurgery
Official title: To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Postoperative Complications
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 65 years old and above undergoing elective major onco- surgeries .

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.

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

Primary outcomes:
measure: To study incidence of postoperative complications in frail patients
timeFrame: upto 7 days
Secondary outcomes:
measure: Length of ICU stay
timeFrame: upto 240 hours.
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
state: Delhi
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute
Study officials:
affiliation: Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India
name: Anita Kulkarni, MD
role: PRINCIPAL_INVESTIGATOR
References: