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

NCT ID: NCT02235636

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Background Da VinciĀ® 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).

Conditions

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Surgical Suturing for Closure of Gastrotomy Laparoscopic Suturing Robotic Surgical Suturing

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic group

No interventions assigned to this group

Robotic group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Philip Wai Yan Chiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip W Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, The Chinese University of Hong Kong

Locations

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CUHK Jockey Club Minimally Invasive Surgical Skills Center

Hong Kong SAR, , China

Site Status

Countries

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China

Other Identifiers

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098-12

Identifier Type: -

Identifier Source: org_study_id

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