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NCT Number: NCT02235636

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

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

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Key information

Conditions

Surgical Suturing for Closure of Gastrotomy Laparoscopic Suturing Robotic Surgical Suturing

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CUHK Jockey Club Minimally Invasive Surgical Skills Center

Hong Kong SAR, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 10, 2014
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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