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Clinical Trials/NCT05721391
NCT05721391
Completed
N/A

To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries

Rajiv Gandhi Cancer Institute & Research Center, India2 sites in 1 country80 target enrollmentMarch 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
80
Locations
2
Primary Endpoint
To study incidence of postoperative complications in frail patients
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
July 12, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

Dr Anita Kulkarni

Principal investigator

Rajiv Gandhi Cancer Institute & Research Center, India

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

Outcomes

Primary Outcomes

To study incidence of postoperative complications in frail patients

Time Frame: upto 7 days

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

Secondary Outcomes

  • Length of ICU stay(upto 240 hours.)

Study Sites (2)

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