| CTRI Number |
CTRI/2017/11/010475 [Registered on: 13/11/2017] Trial Registered Prospectively |
| Last Modified On: |
05/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the reasons for cancellation of operations in a multispeciality hospital for next 6 months |
|
Scientific Title of Study
|
"Factors affecting cancellation of elective operation on the day of proposed surgery in a tertiary care hospital: a prospective, cross-sectional study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
West
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesioloy and Critical Care, Deen dayal
Upadhyay Hospital , Hari Nagar, New Delhi - 110064 |
| 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 Ajay Kumar |
Deen Dayal Upadhyay Hospital, Govt of NCT of delhi |
Department of
Anaesthesiology &
Critical Care, Deen
Dayal Upadhyay
Hospital, Govt. of Delhi
Hari Nagar, New Delhi -
110064
West
DELHI |
9718990114
ajayannu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Deen Dayal Upadhyay Hospital, Hari Nagar, Delhi-110064, Govt of NCT of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients of either sex, posted for elective
surgery in Main OT-1 and Main OT-2 posted for
surgery requiring presence of an
anaesthesiologist., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
We will study the reasons for cancellation of elective cases on the
day of scheduled surgery in the Main OT-1 and Main OT-2 located in
the main OT complex. This will be a
study of all types of elective surgical procedures except plastic
surgery and neurosurgery to be studied prospectively over 06 months. |
|
| ExclusionCriteria |
| Details |
Procedures that did not require presence of an anaesthetist will be
excluded.
Any case posted as an emergency case outside the OT list will be
excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the rate of cancellation of elective
surgical procedures |
prospectively for 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the various reasons leading to
cancellation of operation on the day of proposed
surgery,their prevalence and relationship to any
intervention.
To determine reasons particularly attributable to
a speciality. |
prospectively for 06 months |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "2178"
Final Enrollment numbers achieved (India)="2178" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2017 |
| Date of Study Completion (India) |
15/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After obtaining approval from the
institutional ethics committee this study will be conducted at Deen Dayal
Upadhyay Hospital (DDUH), which is one of the largest tertiary care Government
Hospital in West Delhi. It has 640 beds (as on 11 august 2017) and performs
both emergency and elective surgeries. The Operating room in the hospital are serving all specialties
including general surgery, ear, nose, and throat, Ophthalmology, gynecology,
orthopedics, plastic surgery, and neurosurgery. All the elective orthopaedic
and gynaecologic cases are performed in Main OT-1 while all the elective Ear,
Nose and Throat, Eye and General Surgery cases are performed in Main OT-2.
This will be a prospective, cross
sectional study of all types of elective surgical procedures except plastic
surgery and neurosurgery. Data will be collected prospectively for 06 months.
We will study the rate and reasons for cancellation
of elective cases on the day of scheduled surgery in the Main OT-1 and Main
OT-2 located in the main OT complex of DDUH which has total strength of 08
operating theatres.
Exclusion criteria:
Procedures that did not require presence
of an anaesthetist will be excluded.
Any
case posted as an emergency case outside the OT list will be excluded.
Definition:
A posted case will be defined as a case
scheduled in the elective surgery OT list, which is submitted to the respective
operation theatre on the last working day before the day of proposed surgery.
Any supplementary list provided on the morning of surgery will also be included
in the database.
A
cancelled case will be defined as a case that has been scheduled in OT list and
has not been operated on the day of proposed surgery.
Causes
of cancellation will be divided into following categories:
1.
Patient related factors which include patient “no show,†patient’s refusal to
sign consent form, noncompliance of preoperative orders by the patient and
death prior to the date of the operation etc.
2.
Preoperative preparation causes such as the need for further optimization,
further investigation, abnormal investigation reports or change in the
treatment plan, change in medical status etc.
3.
Facility related factors including lack of OT time; no ICU beds; unavailability
of equipment, implants; staff administrative errors such as incorrect booking,
surgery done as an emergency; non-availability of anaesthesist, surgeon or
technical staff etc.
4.
Other causes as per database.
Data
will be collected from OT lists, operation theatre registers and patient
medical records and will be analyzed statistically. |