Impact of Frailty on Postoperative Complications in Oncosurgery

Postoperative Complications Clinical Trial

— Frailty  

Official title:

To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721391
• Other study ID #: RGCI Frailty
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 12, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

Patients undergoing major onco-surgey

Exclusion Criteria:

• Patient refusal to participate

• Age <65 years.

• Emergency surgery

• Pre-existing dementia

• Language barrier

Related Conditions & MeSH terms

• Frailty
• Postoperative Complications

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute	Delhi
India	Rajiv Gandhi Cancer Institute and Research Centre	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study incidence of postoperative complications in frail patients	Postoperative major complications as myocardial infarction, Respiratory failure, cerebrovascular event, renal failure , re-exploration will be noted and statistically analysed.	upto 7 days
Secondary	Length of ICU stay	Time from admission to the PACU to shifting to the ward will be noted in hours.	upto 240 hours.