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CompletedNCT05721391

Impact of Frailty on Postoperative Complications in Oncosurgery

To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India · Academic / Other
Sex
All
Age
65 Years – 90 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2022-03-01
Primary completion
2023-06-30
Completion
2023-07-12
First posted
2023-02-10
Last updated
2023-07-14

Locations

2 sites across 1 country: India

Source: ClinicalTrials.gov record NCT05721391. Inclusion in this directory is not an endorsement.

Impact of Frailty on Postoperative Complications in Oncosurgery (NCT05721391) · Clinical Trials Directory