NCT06164158

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

November 21, 2023

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Study Group

EXPERIMENTAL

Half were made to watch the procedural videos and learn the steps of the procedure and then made to perform procedure

Other: Procedural Videos

Control Group

EXPERIMENTAL

Other half group did not watch the procedural videos and were made to perform procedure.

Other: No procedural videos

Interventions

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.

Study Group

No procedural videos

Control Group

Eligibility Criteria

AgeUp to 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Those residents who did not wish to participate
  • Those with less than 3 months of training.
  • Consultant surgeons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, 44000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2023

First Posted

December 11, 2023

Study Start

September 1, 2023

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations