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

Laparoscopic Suturing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235636
• Other study ID #: 098-12
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: September 8, 2014
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong SAR, China: Chinese University of Hong Kong
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparoscopic Suturing
• Robotic Surgical Suturing
• Surgical Suturing for Closure of Gastrotomy

Locations

Country	Name	City	State
China	CUHK Jockey Club Minimally Invasive Surgical Skills Center	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of success in closure of gastrotomy	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	No
Secondary	Pneumatic bursting pressure for gastric incision	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	No
Secondary	Assessment of participant workload	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	No