FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/11/010366 [Registered on: 03/11/2017] Trial Registered Retrospectively
Last Modified On: 02/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   Costs incurred by patients and their family members for the surgical treatment at Tata Memorial Centre 
Scientific Title of Study   To study expenditure on major Gastro-intestinal cancer surgery in Tata Memorial Centre 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1110 version 1.3 dated 31.07.2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Guruchannabasavaiah 
Designation  SPECIALIST SENIOR RESIDENT 
Affiliation  Tata Memorial Hospital  
Address  Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  2224177000  
Fax    
Email  gr1surg.ktm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Guruchannabasavaiah 
Designation  SPECIALIST SENIOR RESIDENT 
Affiliation  Tata Memorial Hospital  
Address  Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  2224177000  
Fax    
Email  gr1surg.ktm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shailesh V Shrikhande 
Designation  Professor and GI HPB Surgeon F 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital 12th Floor Homibhaba Buidling Room No 1222 Dr Ernest Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820224761  
Fax    
Email  svsclinresearch@gmail.com  
 
Source of Monetary or Material Support  
No financial involvement 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr Ernest Borges Marg Parel Mumbai 
Type of Sponsor  Research institution and hospital 
 
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 BGuruchannabasavaiah  Tata Memorial Hospital  Department of Gastroenterology 3rd floor room number 325 Homibhaba building Dr Ernest Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA 
2224177000

gr1surg.ktm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gastrointestinal cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Patients registered under GI-DMG
2) Provide informed written consent
3) Willing to voluntarily complete study assessments
4) Patients who have undergone a radical major GI and HPB cancer resection 
 
ExclusionCriteria 
Details  1)Upfront inoperable disease
2)Patients with metastatic disease where surgery is contraindicated
3)Joint clinic decision to not perform surgery in a given clinical situation  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess costs of following surgeries in general and private patients
Pancreaticoduodenectomy
Radical gastrectomy with D2 Lymphadenectomy
Low anterior resection
Hepatectomy
 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1) Total cost incurred (in Indian Rupees INR) by patient and relatives for surgery, hospital stay, ICU stay, consumables, radiological investigations, other clinical laboratory and pharmacy
2) To compare costs of treatment in General and Private category semiprivate deluxe and private all included
Cost difference in uncomplicated and complicated surgery 
1 year 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2013 
Date of Study Completion (India) 15/07/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Introduction:Health economics is increasingly being recognized as an important aspect of health care management. Unlike developed countries, India does not have comprehensive medical insurance coverage. Majority of our patients end up in paying from their own pocket. Nearly 75% of health spending in India is out of pocket expenditure (OOP) and this OOP pushes 39 million Indians to poverty every year. Increasing use of technology in investigation as well as surgery and medical expenses all add to the cost of treatment. India spends only 4% of its GDP on Total Healthcare Expenditure (THE), when compared to other Low to middle income countries (LMIC) in which they spend 5.7% of their GDP. According to an analysis, private expenditure on health in India is close to 78% compared to 14% in the Maldives, 29% in Bhutan, 53% in Sri Lanka, 31% in Thailand and 61% in China .

Major Gastrointestinal (GI) and Hepato-Pancreato-Biliary (HPB) cancer surgeries are supra-major surgeries with their own set of complications which can result in significant morbidity. Whenever there is increased morbidity, cost of treatment also increases. A recent large series from TMH has shown that Pancreaticoduodenectomy (PD) was associated with morbidity of 20-30%; radical gastrectomy has morbidity of 12%6; low rectal cancer surgery 26.5% morbidity. While these results are comparable to other centers of excellence worldwide, the costs incurred for these complications must have added to these already expensive procedures. The median cost for PD in USA in 2012 is $30, 9372. This cost is on the background of GDP and total health expenditure (THE) of USA which is 17% of total GDP. If an average American national is to spend OOP for the costs of this surgery (in addition to the costs of treating pancreatic cancer as a whole), only 5 % of the population of USA would be able to afford this expense in one of the most affluent societies of the world. In contrast, there is no published data available from the Indian subcontinent for PD, a surgery that is both complex and uncommonly performed for a disease with a much lower incidence in this part of the world.  It is naturally expected that costs will be much lower given the GDP of 6% of India; thus there is an urgent need to generate data regarding this assumption that complex GI and HPB surgeries would be affordable to a large number of Indian patients.

This study attempts to analyze costs of major GI and HPB cancer surgeries in Tata Memorial Centre.

Primary Aim:To assess costs of following surgeries in general and private patients  pancreaticoduodenectomy, Radical gastrectomy with D2 Lymphadenectomy

Low anterior resection, Hepatectomy

Methodology

At the time of admission, patients and their relatives will be given a proforma to document the amount spent  (in INR) during each stage of their management including baseline and pre-operative blood tests, radiological imaging, endoscopies, surgical costs including consumables ,  ICU care and room charges till the day of discharge.Costs incurred by patients and their family members for the surgical treatment from the time of registration till post-operative recovery (till the day of discharge) will be assessed.

 
Close