FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
Close