Robotic Surgical ProceduresNCT04869995
Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery
An observational study of Robotic Surgical Procedures, run by Centre Hospitalier de Troyes at 1 site in France.
Trial summary
Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Robotic Surgical Procedures
- What is being tested?
- Interview
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will comprise senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery.
Who may be able to join
- Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, or urologists).
- Having completed a robot-assisted training
- Commonly doing laparoscopic surgery
Who cannot join
- Those who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery (a Qualitative Study)
Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre.
Interviewing senior surgeons trained for doing robot-assisted surgery, this qualitative study is expected to provide new insights to understand the surgeons' behavioral changes when using a robot.
This study will contribute to improving training programs in robot-assisted surgery.
- Conditions
- Robotic Surgical Procedures
- Being tested
- Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
An individual semi-structured interview per surgeon, according to an interview guide.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elicitation of the surgeons' perception
Elicitation of the surgeons' perception of practices and behavior changes when doing robot-assisted surgery.
Measured: = interview duration (about 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Sep 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Troyes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869995
- Sponsor's protocol ID
- BehavRobot
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cormi C, Parpex G, Julio C, Ecarnot F, Laplanche D, Vannieuwenhuyse G, Duclos A, Sanchez S. Understanding the surgeon's behaviour during robot-assisted surgery: protocol for the qualitative Behav'Robot study. BMJ Open. 2022 Apr 7;12(4):e056002. doi: 10.1136/bmjopen-2021-056002.
PubMed 35393313
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery (a Qualitative Study)
- ClinicalTrials.gov ID
- NCT04869995
- Acronym / sponsor ID
- BehavRobot
- Conditions
- Robotic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier de TroyesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre.
Interviewing senior surgeons trained for doing robot-assisted surgery, this qualitative study is expected to provide new insights to understand the surgeons' behavioral changes when using a robot.
This study will contribute to improving training programs in robot-assisted surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: InterviewSenior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will comprise senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, and urologists) having completed their robot-assisted surgery training, and commonly doing laparoscopic surgery.
Key inclusion criteria (3 listed)
- Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, or urologists).
- Having completed a robot-assisted training
- Commonly doing laparoscopic surgery
Key exclusion criteria (1 listed)
- Those who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAn individual semi-structured interview per surgeon, according to an interview guide. | Other | Intervention |
Primary outcome
Elicitation of the surgeons' perception
Time frame: = interview duration (about 30 minutes)
Elicitation of the surgeons' perception of practices and behavior changes when doing robot-assisted surgery.
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 2 Mar 2023.
- Derived from this study: PubMed 35393313Cormi C, Parpex G, Julio C, Ecarnot F, Laplanche D, Vannieuwenhuyse G, Duclos A, Sanchez S. Understanding the surgeon's behaviour during robot-assisted surgery: protocol for the qualitative Behav'Robot study. BMJ Open. 2022 Apr 7;12(4):e056002. doi: 10.1136/bmjopen-2021-056002.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Robotic Surgical Procedures, run by Centre Hospitalier de Troyes at 1 site in France.
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 3 inclusion and 1 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 2 Mar 2023. 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 France. 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?
Elicitation of the surgeons' perception (time frame: = interview duration (about 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869995, which also lists 1 linked publication.
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 2 Mar 2023.