NCT03407235

Brief Summary

Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 11, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

January 16, 2018

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to completion of laparoscopic tasks.

    5 minutes

Study Arms (1)

Laparoscopic Novices

OTHER

Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch. Time to completion is recorded.

Device: Computerized Laparoscopic TrainerDevice: Box trainer with eye patch

Interventions

Gold standard laparoscopic trainer using simulated computerized equipment.

Laparoscopic Novices

Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch

Laparoscopic Novices

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Laparoscopic Novices
  • years
  • All genders

You may not qualify if:

  • Previous laparoscopic surgical experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Of Nottingham

Derby, DE22 3NE, United Kingdom

Location

The Medical School, University of Nottingham, Royal Derby Hospital.

Derby, DE22, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

December 11, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

October 15, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations