| CTRI Number |
CTRI/2020/10/028649 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Surgery complications rates in pre and post COVID era |
|
Scientific Title of Study
|
Comparative analysis of perioperative morbidity at a tertiary cancer care center in the pre and post COVID era – has the tide changed? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deep Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi |
| Address |
Homi Bhabha Cancer Hospital
Dept of Surgical Oncology
Ghanti Mill Road, Lahartara
Old Loco Colony,Shivpurwa
Varanasi (U.P)
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7204438439 |
| Fax |
|
| Email |
deepjain12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deep Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi |
| Address |
Homi Bhabha Cancer Hospital
Dept of Surgical Oncology
Ghanti Mill Road, Lahartara
Old Loco Colony,Shivpurwa
Varanasi (U.P)
UTTAR PRADESH
221002
India |
| Phone |
7204438439 |
| Fax |
|
| Email |
deepjain12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deep Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi |
| Address |
Homi Bhabha Cancer Hospital
Dept of Surgical Oncology
Ghanti Mill Road, Lahartara
Old Loco Colony,Shivpurwa
Varanasi (U.P)
UTTAR PRADESH
221002
India |
| Phone |
7204438439 |
| Fax |
|
| Email |
deepjain12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital (HBCH) and Mahamana Pandit Madan Mohan Malviya Cancer Center (MPMMCC) |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Deep Kumar Jain |
Homi Bhabha Cancer Hospital |
HBCH & MPMMCC
Dept. of Surgical Oncology
Ghanti Mill Road, Lahartara, Old Loco Colony, SHivpurwa
Varanasi
UTTAR PRADESH |
7204438439
deepjain12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee- HBCH & MPMMCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (3) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (4) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (5) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (6) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (7) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (8) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (9) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patient that underwent any surgical intervention under regional or general anaesthesia during the period from 1st January to 30th July 2020.
|
|
| ExclusionCriteria |
| Details |
Patients that underwent surgical procedures with palliative intent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri-operative Morbidity based on Clavien dindo grades |
Within 30days from date of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identify patient/disease factors associated increased risk of preoperative morbidity |
Within 30days from date of surgery |
|
|
Target Sample Size
|
Total Sample Size="888"
Sample Size from India="888"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patient that underwent any surgical intervention under regional or general anaesthesia during the study period will be included and divided into two groups Pre-COVID and Post-COVID, depending upon whether the intervention was done prior to or after the occurrence of COVID pandemic in India. Data analysis will include demographic details, diagnosis, associated co-morbidities, intervention performed, date of intervention, date of discharge, intra-op, and post-operative complications graded according to the modified Calvien-Dindo classification |