| CTRI Number |
CTRI/2025/01/079637 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitive |
| Study Design |
Other |
|
Public Title of Study
|
Surgical Safety Checklist - Practices, Barriers and Facilitators: A Qualitative analysis |
|
Scientific Title of Study
|
Examining the views of Surgeons and hospital staff on using the Surgical Checklist |
| Trial Acronym |
ELEPHANT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lovenish Bains |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Surgery,
Maulana Azad Medical College,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9910777700 |
| Fax |
|
| Email |
lovenishbains@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lovenish Bains |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Surgery,
Maulana Azad Medical College,
New Delhi
DELHI
110002
India |
| Phone |
9910777700 |
| Fax |
|
| Email |
lovenishbains@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lovenish Bains |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Surgery,
Maulana Azad Medical College,
New Delhi
DELHI
110002
India |
| Phone |
9910777700 |
| Fax |
|
| Email |
lovenishbains@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
2 BSZ Marg, New Delhi-110002
India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Investigator Initiated] |
|
|
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 Lovenish Bains |
Maulana Azad Medical College |
Department of Surgery, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI |
9910777700
lovenishbains@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAMC MAULANA AZAD MEDICAL COLLEGE 3rd FLOOR ROOM NO 306A BAHADUR SHAH ZAFAR MARG DELHI New Delhi Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Health condition- Only interviews of surgeons, nurses, anesthetist about Surgical Safety Checklist |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants-Surgeon, Nurse, Anesthetist
2. At least 3 years of experience
3. Working in Govt/private/Rural hospitals |
|
| ExclusionCriteria |
| Details |
Medical and Nursing Students under training
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Practices and perceptions of the surgical team on utilisation of the WHO surgical safety checklist
2. Key barriers and facilitators for Surgical Safety Checklist its successful implementation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Key barriers & facilitators for Surgical Safety Checklist its successful implementation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical
Safety Checklist (SSCL) is one measure whose use has shown reduction in
postoperative morbidity and mortality and improved team communication. Despite
implementation in many hospitals throughout the country, there is still lack of
awareness and concern in many health care facilities towards SSCL and its use. This research explores the
implementation of the WHO Surgical Safety Checklist by examining the views of surgeons,
nurses and anaesthetists. Through
qualitative analysis, we aim to identify key practices, barriers, and
facilitators associated with the checklist’s use. The findings will provide
insights into the practical challenges and enablers of checklist
implementation, offering valuable information for improving safety protocols in
surgical settings. The findings will inform strategies to optimize the adoption
and effectiveness of safety checklists in surgical environments. |