NCT02505724

Brief Summary

This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to teach novice surgical faculty an advanced laparoscopic skill.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

July 20, 2015

Last Update Submit

July 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Technical Skill

    Technical skill as measured by the Objective Structured Assessment of Technical Skill (OSATS) global rating scale. Participants are scored on 4 domains from 0-5 (respect for tissue, precision of operative technique, economy of movements, confidence of movements). The maximum possible score is 20.

    Two weeks post intervention

Study Arms (2)

Conventional training

ACTIVE COMPARATOR

Participants received access to a web-based tutorial for laparoscopic suturing and a box trainer for independent practice

Behavioral: conventional training

Intervention

EXPERIMENTAL

Participants received access to a web-based tutorial for laparoscopic suturing and a box trainer for independent practice. In addition, they received two 1/2 hour peer-coaching sessions

Behavioral: peer-coaching

Interventions

After completing the initial assessment, faculty randomized to the conventional training group received a link to a web-based instructional video. In addition, they were given a laparoscopic box trainer, laparoscopic instruments and sutures that they could use to practice with at their leisure.

Conventional training
peer-coachingBEHAVIORAL

Faculty randomized to the peer-coaching group received ½ hour of peer-coaching after completing the initial assessment on the simulator. Each faculty member sutured on the box trainer while being observed by his or her peer-coach. All study participants had the same peer-coach.After the coaching session, study participants received a link to the web-based video as well as the box trainer and supplies to independently practice laparoscopic suturing. Similar to individuals in the control group, no specific guidance regarding the amount of independent practice was given.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • surgical faculty in the division of general surgery or obstetrics and gynaecology.
  • novices in laparoscopic suturing (performed \<20 intra-corporeal stiches and knots)

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 22, 2015

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07