| CTRI Number |
CTRI/2025/03/083423 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Simulation based medical education] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessing the role of skills lab in improving the skills of general surgery doctors. |
|
Scientific Title of Study
|
Surgical Skills Lab And Their Effectiveness In Enhancing The Competency Of General Surgery Residents: A Randomised Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Isha Shah |
| Designation |
Junior Resident, department of general surgery |
| Affiliation |
Department of general surgery, rohilkhand medical college and hospital |
| Address |
room no. 2, Department of Surgery, Division General Surgery, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8587998490 |
| Fax |
|
| Email |
isha.shah2438@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Isha Shah |
| Designation |
junior resident, department of general surgery |
| Affiliation |
Department of general surgery, rohilkhand medical college and hospital |
| Address |
room no. 2, Department of Surgery, Division General Surgery, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8587998490 |
| Fax |
|
| Email |
isha.shah2438@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Isha Shah |
| Designation |
junior resident, department of general surgery |
| Affiliation |
Department of general surgery, rohilkhand medical college and hospital |
| Address |
room no. 2, Department of Surgery, Division General Surgery, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8587998490 |
| Fax |
|
| Email |
isha.shah2438@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Bareilly, 243006 |
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college and hospital |
| Address |
Department of general surgery, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Human resourse development MDMS thesis support programe |
Shastri Bhawan, New Delhi - 110001 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Isha Shah |
Skill lab room no 1, Department of general surgery |
Skill lab, Room No. 1, Department of General Surgery, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH |
8587998490
isha.shah2438@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMMITEE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation-based medical education in Skills lab |
Simulation-based medical education was provided to participants under the following headings -
for Basic skills- 1. Ryles tube insertion
2.Foleys Catheterization
3. IV cannulation
4. basic bandaging
Advanced skills-
1.BLS
2.ACLS
3.Suturing
4.knot Tying
Laparoscopic skills-
1. dexterity
2. depth perception
3. object handling
4. navigation |
| Comparator Agent |
the Participants initial assessment of the skills to be learned in the skills lab will we used as a control |
A checklist shall be used to assess participants on the following skills before attending the skills lab- for Basic skills- 1. Ryles tube insertion 2.Foleys Catheterization 3. IV cannulation 4. basic bandaging Advanced skills- 1.BLS 2.ACLS 3.Suturing 4.knot Tying Laparoscopic skills- 1. dexterity 2. depth perception 3. object handling 4. navigation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All the general surgery residents pursuing Residency from Rohilkhand Medical College and Hospital in the Department of General Surgery from year 2024-2025 |
|
| ExclusionCriteria |
| Details |
residents not pursuing general surgery residency from rohilkhand medical college and hospital, Barielly in the year 2024-2025 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Points scored on the surgical skill checklist |
T0 = before skills lab training
T1 = 10 minutes skills lab training
T2 = 1 month after skills lab training |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
07/04/2025 |
| 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 skill labs or simulation-based medical education (SBME) for surgical residents is aimed at training and enhancing surgical skills in a safe environment for residents to practice them develop their proficiency before applying them in real-life scenarios. Among the many attributes of simulation, the most important is that it permits exploration and repeated practice in a setting that fosters permission to fail and the opportunity to learn from one’s mistakes making it the perfect tool to learn skills before they are applied in real-life scenarios. The curriculum may include modules to increase familiarity with surgical instruments, suturing skills, basic laparoscopic training, airway management training and simulated code and critical care management. Basic didactic principles are usually taught in parallel with skills training. Despite advancements in medical education, there exists a gap in the surgical knowledge and practical application of surgical skills resulting in poor overall patient delivery, skills lab and SBME help to bridge this existing gap in surgical training. Few studies are available in the literature which have tested surgical skills and their assessment both in the skill lab and in real-life scenarios. This study will endeavor to enlighten us on both these aspects. |