| CTRI Number |
CTRI/2021/09/036940 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
PROCESS AUDIT |
| Study Design |
Other |
|
Public Title of Study
|
Audit on Surgical Safety Checklist in patients who underwent operation |
|
Scientific Title of Study
|
Surgical Safety Checklist |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABDUL BASITH |
| Designation |
General Surgeon |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44/54 Tilak Nagar Main Rd, Bannerghatta Approach Road Layout, 4th T Block East, Tilak Nagar, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India |
| Phone |
9900718036 |
| Fax |
|
| Email |
abasith09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ABDUL BASITH |
| Designation |
General Surgeon |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44/54 Tilak Nagar Main Rd, Bannerghatta Approach Road Layout, 4th T Block East, Tilak Nagar, Jayanagar, Bengaluru, Karnataka 560041
Bangalore
KARNATAKA
560041
India |
| Phone |
9900718036 |
| Fax |
|
| Email |
abasith09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABDUL BASITH |
| Designation |
General Surgeon |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44/54 Tilak Nagar Main Rd, Bannerghatta Approach Road Layout, 4th T Block East, Tilak Nagar, Jayanagar, Bengaluru, Karnataka 560041
Bangalore
KARNATAKA
560041
India |
| Phone |
9900718036 |
| Fax |
|
| Email |
abasith09@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAGAR HOSPITALS BANGALORE |
|
|
Primary Sponsor
|
| Name |
SAGAR HOSPITALS |
| Address |
44/55 Tilak Nagar Main Rd, Bannerghatta Approach Road Layout, 4th T Block East, Tilak Nagar, Jayanagar, Bengaluru, Karnataka 560041 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Abdul basith |
SAGAR HOSPITALS |
#44/54, 30th Cross Road, Tilak Nagar bangalore Department of General Surgery Room number 9 OPD
Bangalore
KARNATAKA |
9900718036
abasith09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAGAR HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Surgical safety Checklist |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All surgical procedure done at major operation theatre in sagar hospitals |
|
| ExclusionCriteria |
| Details |
All operation done at minor operation theatre and on patients <18 year old |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether the surgical team was compliant with process of completing WHO Surgical Safety Checklist for every operative/surgical procedure at Sagar Hospital operation room
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reaudit after succesfully making changes to safety checklist if any |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2021 |
| 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="1"
Months="0"
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
|
Surgical safety checklist is set of safety checks designed to safeguard and improve team performance at critical points in patients intra operative pathway. Aim of our study was to assess whether the surgical team was compliant with process of completing WHO Surgical Safety Checklist for every Surgery at Sagar Hopsitals operating room . This is process Audit to be conducted in Sagar Hospitals. All surgical operation in major ot complex were included in study . Operations <18 year old were excludedThe data was collected using trained observer through a direct observation using a standard checklist in google forms. At the end of study data will be nalysed to assess whether the surgical team was compliants with process of completing WHO Surgical Safety Checklist for every operative / surgical procedure . Compliance will be considered Excellent if data points collected >90 , Acceptable- 75% to 90% Poor- <75% |