A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices

September 8, 2014 updated by: Philip Wai Yan CHIU, Chinese University of Hong Kong

Da Vinci Robot Compared to Laparoscopic Suturing for Closure of Gastric Incision Among Novice: a Randomized Cross Over Trial

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

Study Overview

Status

Completed

Conditions

Detailed Description

Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform complex minimally invasive surgical procedures across different specialties. This study aimed to investigate the impact of DVRSS on surgical proficiencies among inexperience novice surgeons and compared to conventional laparoscopic surgery.

Methods Twenty medical students (n=20) without surgical experience were enrolled. After a constructive training for basic surgical techniques, participants were randomly allocated into DVR or laparoscopy group. Participants were asked to close five cases (also named five tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time, successful closure rate and pneumatic bursting pressure of gastric incision withstanding were recorded. In addition, participant performance and workload were quantified by using performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index (NASATLI).

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong SAR, China
        • CUHK Jockey Club Minimally Invasive Surgical Skills Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical students with no prior experience in surgery

Description

Inclusion Criteria:

  • Medical Students with no prior surgical experience

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Laparoscopic group
Robotic group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Task performance
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of success in closure of gastrotomy
Time Frame: 1 day
The success in closure of the standardized gastrotomy was defined as followings: (1) The gastrotomy must be closed with 20 minutes using a 10 cm-long suture with intracorporeal knots tying; (2) Sutures should not be broken during the experiment.
1 day
Pneumatic bursting pressure for gastric incision
Time Frame: 1 day
The efficiency of the two groups in using DVRSS and laparoscopic suturing for closure of gastrotomy was assessed by the maximal pneumatic bursting pressure that the suture line could withstand.
1 day
Assessment of participant workload
Time Frame: 1 day
Participant workload was assessed by using National Aeronautics and Space Administration-task load index scale (NASATLX) after completion of each task. The scale focused on six domains, including mental, physical and temporal demand, as well as performance, effort and frustration.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Philip W Chiu, MD, Department of Surgery, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 098-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Laparoscopic Suturing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe