Impact of Frailty on Postoperative Complications in Oncosurgery

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India (Other)
Overall Status
Recruiting
CT.gov ID
NCT05721391
Collaborator
(none)
100
2
14
50
3.6

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Mar 30, 2023
    Anticipated Study Completion Date :
    Apr 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Non Frail Group

    The patients in no frail group did not have any component of Frailty criteria

    Pre Frail Group

    The patients in prefrail Group had 1-2 component of Frailty criteria.

    Frail Group

    The patients in Frail Group had 3-5 component of Frailty criteria.

    Outcome Measures

    Primary Outcome Measures

    1. To study incidence of postoperative complications in frail patients [upto 7 days]

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

    Secondary Outcome Measures

    1. Length of ICU stay [upto 240 hours.]

      Time from admission to the PACU to shifting to the ward will be noted in hours.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rajiv Gandhi Cancer Institute and Research Centre New Delhi Delhi India 110085
    2 Rajiv Gandhi Cancer Institute Delhi India 110085

    Sponsors and Collaborators

    • Rajiv Gandhi Cancer Institute & Research Center, India

    Investigators

    • Principal Investigator: Anita Kulkarni, MD, Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Anita Kulkarni, Senior Consultant, Rajiv Gandhi Cancer Institute & Research Center, India
    ClinicalTrials.gov Identifier:
    NCT05721391
    Other Study ID Numbers:
    • RGCI Frailty
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2023