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Impact of Frailty on Postoperative Complications in Oncosurgery

To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05721391
Acronym
Frailty
Enrollment
80
Registered
2023-02-10
Start date
2022-03-01
Completion date
2023-07-12
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Postoperative Complications

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.

Interventions

None listed

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients undergoing major onco-surgey

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
To study incidence of postoperative complications in frail patientsupto 7 daysPostoperative major complications as myocardial infarction, Respiratory failure, cerebrovascular event, renal failure , re-exploration will be noted and statistically analysed.

Secondary

MeasureTime frameDescription
Length of ICU stayupto 240 hours.Time from admission to the PACU to shifting to the ward will be noted in hours.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026