| CTRI Number |
CTRI/2022/08/044722 [Registered on: 17/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of COVID-19 on patients waiting surgery and there outcome |
|
Scientific Title of Study
|
COVID 19: From resource restriction to surgical services. How we waived off the waves |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Shankar Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Medical College Hospital, Kolkata |
| Address |
Department of Surgical Gastroenterology
Green Building First floor
88, College Street
29/4, Madhu Pandit Road
Talpukur
Barrackpore
700123 Kolkata WEST BENGAL 700073 India |
| Phone |
9874338353 |
| Fax |
|
| Email |
drrsbiswas1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ravi Shankar Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Medical College Hospital, Kolkata |
| Address |
Department of Surgical Gastroenterology
Green Building First floor
88, College Street
29/4, Madhu Pandit Road
Talpukur
Barrackpore
700123
Kolkata WEST BENGAL 700073 India |
| Phone |
9874338353 |
| Fax |
|
| Email |
drrsbiswas1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ravi Shankar Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Medical College Hospital, Kolkata |
| Address |
Department of Surgical Gastroenterology
Green Building First floor
88, College Street
29/4, Madhu Pandit Road
Talpukur
Barrackpore
700123
Kolkata WEST BENGAL 700073 India |
| Phone |
9874338353 |
| Fax |
|
| Email |
drrsbiswas1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College Hospital
88, College Street
College Square
Kolkata
700073
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
Medical College Hospital Kolkata |
| Address |
Department of Surgical Gastroenterology
Green Building First floor
88, College Street
College Square
|
| 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 |
| Ravi Shankar Biswas |
Medical College Hospital, Kolkata |
Department of Surgical gastroenterology
Green Building First floor
88 College Street
College Square
700073 Kolkata WEST BENGAL |
9874338353
drrsbiswas1@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 |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients attending the department of surgical gastroenterology on and after 12 March 2020
2. Control group includes patients treated till February 29, 2020. Patients will be matched in 1:1
ratio with same surgical pathology who had undergone the identical treatment by the same
team. |
|
| ExclusionCriteria |
| Details |
1. Patients expired undiagnosed.
2. Patients transferred out to other department and lost to follow up. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of the study were 30-day mortality and complications in patients included in
the study compared with a tightly matched control group. |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Investigation of how COVID-19 (patients diagnosed of COVID 19 after index consultation at
surgical gastroenterology department) compares with other well-known risk factors |
30 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="344" Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "344"
Final Enrollment numbers achieved (India)="344" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Wynants L, Van Calster B, Bonten MMJ, Collins GS, Debray TPA, De Vos M, Haller MC, Heinze
G, Moons KGM, Riley RD, Schuit E, Smits LJM, Snell KIE, Steyerberg EW, Wallisch C, van Smeden
M (2020) Prediction models for diagnosis and prognosis of covid-19 infection: systematic review and
critical appraisal. BMJ 369:m1328
2. Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J (2020)
Cancer patients in SARS CoV- 2 infection: a nationwide analysis in China. Lancet Oncol
21(3):335–337 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since December 2019, the world is struggling against Coronavirus Disease 2019 (COVID-19) and in the past months, the life of more than one-third of the planet’s population has radically changed. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has shown to be a very contagious virus potentially causing complicated atypical pneumonia and associated with significant mortality. Despite initially confined to Hubei province, China and Asia, COVID-19 promptly spread to western countries, and in March 11, 2020, the World Health Organization (WHO) declared a public health emergency of international concern. By early April, we are counting over 1,500,000 cases and 88,000 deaths worldwide, with 209 countries involved over 4 continents. India recorded its first case of COVID-19 on January 27, 2020 and was certainly the one suffering the most by the sudden outbreak of the disease. Indeed, SARS-CoV-2 rapidly spread throughout the country by the end of April, challenging the healthcare system toward its collapse, increasing the mortality rate and raising the question concerning the need for special measures to contain the crisis. The Indian Government announced extraordinary measures to contain the spread of the pandemic, by means of nationwide lockdown. COVID-19 outbreak seriously stressed the healthcare system worldwide, with the urgent need of extra ICU beds, dedicated hospital paths, personnel training, and infection control measures. Care of diseases outside the COVID-19 has rapidly changed, and healthcare providers are currently adapting to maximize and properly allocate resources. Surgical activity has shifted to pursue only emergency and elective cancer cases as described in different specialties. Furthermore, the big picture and the full impact was still unknown as its effects on economy, hospital infrastructure, healthcare strategy, and prognosis of oncologic patients. Indeed, people with cancer suffered the most by this worldwide outbreak as the access to surgery is limited by the significant reduction in available resources, eventually influencing the decision making and the therapeutic allocation of patients. With a nationwide lockdown starting on March 25, 2020 there is severe disruption of health care services being provided to non-COVID patients. This problem was intensified when Medical College and Hospital, Kolkata was declared as tertiary level COVID hospital on May 07, 2020 with reservation and diversion to resources to COVID affected patient care services. Resumption of non COVID non-emergency patient care began in our institute from June 16, 2020. |