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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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