Surgical Suturing for Closure of GastrotomyNCT02235636
A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices
An observational study of Surgical Suturing for Closure of Gastrotomy and Laparoscopic Suturing, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and conventional Laparoscopic surgical suturing among novice Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Suturing for Closure of Gastrotomy, Laparoscopic Suturing, Robotic Surgical Suturing
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Medical students with no prior experience in surgery
Who may be able to join
- Medical Students with no prior surgical experience
Who cannot join
- Surgeons
- Age < 16 or > 60
- Disability and not able to control the Da Vinci Robot through the console
Trial locations and contacts
1 site in 1 country.
China1 site
CUHK Jockey Club Minimally Invasive Surgical Skills Center
Hong Kong SAR
About this study
Official title: 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
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic group | Not described | |
| Robotic group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Suturing for Closure of GastrotomyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan Chiu, Chinese University of Hong Kong
- Investigators
- Philip W Chiu, MD, Principal investigator, Department of Surgery, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235636
- Sponsor's protocol ID
- 098-12
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Da Vinci Robot Compared to Laparoscopic Suturing for Closure of Gastric Incision Among Novice: a Randomized Cross Over Trial
- ClinicalTrials.gov ID
- NCT02235636
- Acronym / sponsor ID
- 098-12
- Conditions
- Surgical Suturing for Closure of Gastrotomy, Laparoscopic Suturing, Robotic Surgical Suturing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic group | – | – |
| Robotic group | – | – |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Medical students with no prior experience in surgery
Key inclusion criteria (1 listed)
- Medical Students with no prior surgical experience
Key exclusion criteria (3 listed)
- Surgeons
- Age < 16 or > 60
- Disability and not able to control the Da Vinci Robot through the console
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Rate of success in closure of gastrotomy
Time frame: 1 day
Pneumatic bursting pressure for gastric incision
Time frame: 1 day
Assessment of participant workload
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip W Chiu, MD principal investigator
Department of Surgery, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Suturing for Closure of Gastrotomy and Laparoscopic Suturing, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task performance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.