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

Completed

• Conditions: Laparoscopic Suturing; Robotic Surgical Suturing; Surgical Suturing for Closure of Gastrotomy

• Registration Number: NCT02235636
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Medical Students with no prior surgical experience

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Task performance	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 Outcome Measures

Name	Time	Method
Pneumatic bursting pressure for gastric incision	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.
Rate of success in closure of gastrotomy	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.
Assessment of participant workload	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.

Trial Locations

Locations (1)

CUHK Jockey Club Minimally Invasive Surgical Skills Center; 🇨🇳 Hong Kong SAR, China