| CTRI Number |
CTRI/2024/01/061056 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Audit |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of the pattern of expenditure for Anesthesia medicines and consumables for major cancer surgeries at a cancer care center in north India |
|
Scientific Title of Study
|
A Health Economic Study on the Expenditure on Anaesthesia Drugs and Consumables for Major Oncosurgeries at a Tertiary Cancer Care Centre in North India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor ,Department of Anaesthesiology Critical care and Pain |
| Affiliation |
MPMMCC & HBCH, Varanasi |
| Address |
Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital TMC Varanasi 221005 Uttar Pradesh India
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8617279293 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor ,Department of Anaesthesiology Critical care and Pain |
| Affiliation |
MPMMCC & HBCH, Varanasi |
| Address |
Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital TMC Varanasi 221005 Uttar Pradesh India
UTTAR PRADESH 221005 India |
| Phone |
8617279293 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor ,Department of Anaesthesiology Critical care and Pain |
| Affiliation |
MPMMCC & HBCH, Varanasi |
| Address |
Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital TMC Varanasi 221005 Uttar Pradesh India
UTTAR PRADESH 221005 India |
| Phone |
8617279293 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
|
Source of Monetary or Material Support
|
| No additional fund Required
It is a retrospective study
requiring only past medical records from hospital registry
Infrastructure of Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital TMC Varanasi will be used |
|
|
Primary Sponsor
|
| Name |
Investigator initiated study(Dr Uddalak Chattopadhyay) |
| Address |
MPMMCC AND HBCH VARANASI |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uddalak Chattopadhyay |
MPMMCC VARANASI |
Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital TMC Varanasi 221005 Uttar Pradesh India Varanasi UTTAR PRADESH |
8617279293
uddalak@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MPMMCC HBCH TMC Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C798||Secondary malignant neoplasm of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The study will include patients who underwent major oncosurgery at MPMMCC in the period of 1 January 2023 to 30 June 2023
Patients of adult age group (more than 18 years of age) will be included To assess the pattern of expenditure on anesthesia drugs and consumables incurred by patients who underwent major oncosurgery in a tertiary care cancer center in northern India.
|
|
| ExclusionCriteria |
| Details |
Patients who do not have complete anesthesia billing records or have missing data for any of the variables of interest will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the average expenditure on anesthesia drugs and consumables per patient for major oncosurgeries. |
Retrospective analysis of billing records |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the head of expenditure for drugs and consumables related to anesthesia. |
Retrospective analysis of billing records |
| To evaluate the variation in anesthesia drugs and consumables related expenditure based on patient ASA status. |
Retrospective analysis of billing records |
| To assess the relation of surgical DMG (disease management group and the expenditure on anesthesia drugs and consumables |
Retrospective analysis of billing records |
| To analyze the influence of different surgical procedures on the expenditure on anesthesia drugs and consumables. |
Retrospective analysis of billing records |
| To examine the relationship between anesthesia technique and the expenditure on anesthesia drugs and consumables. |
Retrospective analysis of billing records |
| To find the correlation between the duration of surgery (OT in-out time) and the expenditure on anesthesia drugs and consumables. |
Retrospective analysis of records |
| To explore the differences in expenditure between general and private category patients. |
Retrospective analysis of billing records |
|
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The increasing costs of healthcare services pose a significant challenge for both patients and healthcare systems worldwide. Major oncosurgeries, particularly in tertiary care cancer centers, are complex procedures that involve multidisciplinary teams, advanced technologies, and specialized care.Alongside the surgical intervention itself, anesthesia services play a critical role in ensuring patient safety, comfort, and optimal surgical outcomes. However, anesthesia-related expenditure has been recognized as a substantial component of the overall healthcare costs associated with these procedures. Understanding and analyzing the financial implications of anesthesia services in major oncosurgeries can provide valuable insights for healthcare providers, policymakers, and patients alike. It allows for a comprehensive evaluation of the costs associated with anesthesia techniques, surgical procedures, patient characteristics, and other factors that may influence expenditure. Such insights can contribute to the development of cost-effective strategies, resource allocation optimization, and informed decision-making to enhance the delivery of healthcare services. This retrospective study aims to assess the anesthesia drugs and consumables related expenditure incurred by patients who underwent major oncosurgery at Tata Memorial Centre (MPMMCC) Varanasi. By examining the data collected over a six-month period, we seek to measure the pattern of expenditure on anesthesia drugs and consumables for major oncosurgeries. Through a comprehensive analysis of various variables, including patient ASA physical status, surgical disease management group (DMG), surgical procedure, anesthesia technique, duration of surgery (OT in-out time), patient category (general/private), occupation, yearly income, urgency of surgery, nature of surgery (primary/reoperation), total anesthesia billing, and expenditure breakdown, we aim to gain valuable insights into the expenditure on anesthesia drugs and consumables for major oncosurgeries. Major oncosurgeries, also known as oncologic surgeries, are surgical procedures performed to diagnose, treat, or remove cancerous tumors or lesions from the body. These surgeries are characterized by their complexity and the significant removal of cancerous tissue or affected organs. The primary goal is to eliminate or reduce the cancer’s presence while preserving as much healthy tissue and function as possible. Major oncosurgeries may involve removing tumors, lymph nodes, or nearby tissues that are affected by cancer.
This health economic study seeks to bridge the gap in knowledge regarding anesthesia-related expenditure for major oncosurgeries in tertiary care cancer center. By unraveling the financial implications, we aim to contribute to the body of evidence necessary for informed decision-making, policy development, and resource allocation in the field of anesthesia services, with the overarching goal of improving healthcare delivery and patient outcomes. |