NCT02235636

Brief Summary

To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and conventional Laparoscopic surgical suturing among novice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

September 4, 2014

Last Update Submit

September 8, 2014

Conditions

Surgical Suturing for Closure of GastrotomyLaparoscopic SuturingRobotic Surgical Suturing

Outcome Measures

Primary Outcomes (1)

  • Task performance

    The performance of participants for each task would be assessed by objective scoring scale basing on the task completion time, plus well-defined errors during suturing and tying knot.

    1 day

Secondary Outcomes (3)

  • Rate of success in closure of gastrotomy

    1 day

  • Pneumatic bursting pressure for gastric incision

    1 day

  • Assessment of participant workload

    1 day

Study Arms (2)

Laparoscopic group

Robotic group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Medical students with no prior experience in surgery

You may qualify if:

  • Medical Students with no prior surgical experience

You may not qualify if:

  • Surgeons
  • Age \< 16 or \> 60
  • Disability and not able to control the Da Vinci Robot through the console

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK Jockey Club Minimally Invasive Surgical Skills Center

Hong Kong SAR, China

Location

Study Officials

  • Philip W Chiu, MD

    Department of Surgery, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 10, 2014

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

December 1, 2013

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

CN(1)