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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06164158
Other study ID # ShaheedZABMU123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date November 21, 2023

Study information

Verified date December 2023
Source Shaheed Zulfiqar Ali Bhutto Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS) Islamabad after approval from the Institutional ethics review board. Fifty-four surgical residents in training and who have completed at least 3 months of surgical training were enrolled in the study. After the residents had performed the procedure initially, 27 were made to watch the procedural videos and learn the steps of the procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure. GARS (global assessment rating score) was calculated for each individual during their second procedure. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment of the GARS (global assessment rating score).


Description:

This study was conducted in 2 phases. In Phase-I just after the enrollment, all the residents performed the procedure from which initial GARS (global assessment rating score) assessment was made. Phase-I was followed by allocation into the groups i.e., study and control groups. In phase-2, a video of surgical procedure was obtained through internet. After all residents have done the procedure initially, 27 participants of the study group were made to watch the videos and learn the steps of procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure again. GARS (global assessment rating score) was calculated for each individual in their second procedure which included following scores: 1. Respect for tissue 2. Time and motion 3. Instrument Handling 4. Depth perception 5. Bimanual Dexterity All elements scored between 1-5 with a total of 25 score. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment according to the GARS (global assessment rating score).


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 21, 2023
Est. primary completion date November 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 35 Years
Eligibility Inclusion Criteria: - All the postgraduate trainees in surgery and allied specialties - Age 25 to 35 years - Both Genders - Any year of training with at least 3 months of surgical training. Exclusion Criteria: - Those residents who did not wish to participate - Those with less than 3 months of training. - Consultant surgeons

Study Design


Intervention

Other:
Procedural Videos
A randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS) Islamabad between September 1, 2023 to November 30, 2023 under ethical approval from the Institutional ethical review board.
No procedural videos
No procedural videos

Locations

Country Name City State
Pakistan Shaheed Zulfiqar Ali Bhutto Medical University/PIMS Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The GARS (global assessment rating score). To determine the GARS score of participants before and after watching the procedural video and compare them which include the following
Respect for tissue
Time and motion
Instrument handling
Depth perception
Bimanual dexterity Total number will be calculated in 2 phases and will be out of 25 and the higher the score, the better the trainee is. The main aspect to be seen will be whether the trainee surgeon improved his GARS score following watching procedural video or not.
3 Months
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