| 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
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Marg Parel Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gastrointestinal cancer, |
|
|
Intervention / Comparator Agent
|
|
|
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. |