| CTRI Number |
CTRI/2021/04/032476 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
01/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Surgical /Anaesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study to find out various causes of cancellation of planned surgeries in various Operation theatre of RNT medical college, Udaipur |
|
Scientific Title of Study
|
Reason for elective surgery cancellation in different surgical specialities on the day of surgery in hospitals associated to RNT Medical college, Udaipur - A Prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alka Yadav |
| Designation |
Junior Resident |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesia
RNT Medical College Udaipur Rajasthan
India
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
7023151992 |
| Fax |
|
| Email |
alka.yadav9413@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Verma |
| Designation |
SeniorProfessor |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesia
RNT Medical College Udaipur Rajasthan
India
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414289538 |
| Fax |
|
| Email |
devendra.anaes@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Alka Yadav |
| Designation |
Junior Resident |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
Department of Anaesthesia
RNT Medical College Udaipur Rajasthan
India
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
7023151992 |
| Fax |
|
| Email |
alka.yadav9413@gmail.com |
|
|
Source of Monetary or Material Support
|
| MB Govt hospital, RNT Medical college, udaipur |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
RNT Medical College,Udaipur |
| 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 |
| Dr Devendra Verma |
MB Govt Hospital |
Department of Anaesthetsia, RNT Medical College, Udaipur, Rajasthan, India
Udaipur
RAJASTHAN |
9414289538
devendra.anaes@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RNT medical college and MB Govt hospital, RNT Medical College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients whose elective surgeries will be cancel / postpone on the scheduled day of surgery. |
|
| ExclusionCriteria |
| Details |
All emergency surgeries will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average rate or percentage of cancellation of elective cases |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Various factors for cancellation of elective cases |
8:00am to 2:00pm of working days for 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
01/04/2021 |
| 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
|
After getting approval from institutional ethical committee, prospective hospital based cross sectional study will be conducted in patients of all age group, either sex, planned for a surgery on a particular day will be recruited in the study. Patients whose elective surgery get postponed on scheduled day will be noted. The reason for cancellation will be categorized as hospital related, patient related, surgeon related and anesthetist related factors. |