Surgical Procedure, UnspecifiedNCT07006766
Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
An observational study of Surgical Procedure, Unspecified, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Microsurgical Training Models
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2023to 15 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical residents or individual with no formal microsurgical education.
Who may be able to join
- Participant is able to commit 1-2 hours to the study.
- Participants must either be a surgical resident or an individual with no formal surgery/microsurgery education. Five participants will be placed into each of these two categories.
Who cannot join
- Participant is unable to commit 1-2 hours to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and the "blue-blood" chicken thigh model. This information will be valuable in assessing the utility of implementing a Japanese shirataki konjac noodle model in beginner microsurgical courses for both local and global education and outreach.
Read the detailed description
The significant benefit Japanese shirataki konjac noodle as a model for microsurgical simulation training is that they are very cost effective and allow for acquisition of microsurgical skills in a low stake environment. This is particularly useful for the microsurgery novice to become familiar with the tools and basics of placing microsuture.
In this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.
The following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).
Following these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator's assessment of the models including most and least valuable aspects of each model, ease \& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Microsurgical Training Models
- Keywords
- microsuture, microsurgery, surgical training, microsurgical education, global, accessibility, noodle, synthetic, vessel, anastomosis, patency, education, outreach, low-cost, microsurgical simulation, simulation, vessel simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical Training ModelsOther
Four models will be compared: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel from Microsurgery and Regenerative Medicine (MSRM) lab, and the "blue-blood" chicken thigh model.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical training | Participants will complete pre-exercise surveys, attempt 4 microsurgical anastomoses, and complete post-exercise surveys. Receives: Other: Microsurgical Training Models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Perform Anastomosis
Measured: up to 30 min
Number of Stitches
Measured: up to 30 min
Patency (either Yes or No)
Patency is the condition of being 'open'.
Measured: up to 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start23 Dec 2023
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Poore, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006766
- Sponsor's protocol ID
- 2023-1534
- Other IDs
- A539730
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prunieres GJ, Taleb C, Hendriks S, Miyamoto H, Kuroshima N, Liverneaux PA, Facca S. Use of the Konnyaku Shirataki noodle as a low fidelity simulation training model for microvascular surgery in the operating theatre. Chir Main. 2014 Apr;33(2):106-11. doi: 10.1016/j.main.2013.12.003. Epub 2014 Feb 4.
PubMed 24603055Mohammad S, Hanstein R, Lo Y, Levy IM. Validating a Low-Fidelity Model for Microsurgical Anastomosis Training. JB JS Open Access. 2021 Jul 16;6(3):e20.00148. doi: 10.2106/JBJS.OA.20.00148. eCollection 2021 Jul-Sep.
PubMed 34291182Ng ZY, Honeyman C, Lellouch AG, Pandya A, Papavasiliou T. Smartphone-Based DIY Home Microsurgical Training with 3D Printed Microvascular Clamps and Japanese Noodles. Eur Surg Res. 2023;64(2):301-303. doi: 10.1159/000521439. Epub 2021 Dec 15.
PubMed 34915484
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
- ClinicalTrials.gov ID
- NCT07006766
- Acronym / sponsor ID
- 2023-1534
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- microsuture, microsurgery, surgical training, microsurgical education, global, accessibility, noodle, synthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 5 Jun 2025 (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.
The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and the "blue-blood" chicken thigh model. This information will be valuable in assessing the utility of implementing a Japanese shirataki konjac noodle model in beginner microsurgical courses for both local and global education and outreach.
Detailed description
The significant benefit Japanese shirataki konjac noodle as a model for microsurgical simulation training is that they are very cost effective and allow for acquisition of microsurgical skills in a low stake environment. This is particularly useful for the microsurgery novice to become familiar with the tools and basics of placing microsuture.
In this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.
The following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).
Following these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator's assessment of the models including most and least valuable aspects of each model, ease \& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microsurgical training | – | Other: Microsurgical Training ModelsParticipants will complete pre-exercise surveys, attempt 4 microsurgical anastomoses, and complete post-exercise surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical residents or individual with no formal microsurgical education.
Key inclusion criteria (2 listed)
- Participant is able to commit 1-2 hours to the study.
- Participants must either be a surgical resident or an individual with no formal surgery/microsurgery education. Five participants will be placed into each of these two categories.
Key exclusion criteria (1 listed)
- Participant is unable to commit 1-2 hours to 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 |
|---|---|---|
| Microsurgical Training ModelsFour models will be compared: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel from Microsurgery and Regenerative Medicine (MSRM) lab, and the "blue-blood" chicken thigh model. | Other | Microsurgical training |
Primary outcome
Time to Perform Anastomosis
Time frame: up to 30 min
Number of Stitches
Time frame: up to 30 min
Patency (either Yes or No)
Time frame: up to 30 min
Patency is the condition of being 'open'.
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 5 Jun 2025.
- Background: PubMed 24603055Prunieres GJ, Taleb C, Hendriks S, Miyamoto H, Kuroshima N, Liverneaux PA, Facca S. Use of the Konnyaku Shirataki noodle as a low fidelity simulation training model for microvascular surgery in the operating theatre. Chir Main. 2014 Apr;33(2):106-11. doi: 10.1016/j.main.2013.12.003. Epub 2014 Feb 4.
- Background: PubMed 34291182Mohammad S, Hanstein R, Lo Y, Levy IM. Validating a Low-Fidelity Model for Microsurgical Anastomosis Training. JB JS Open Access. 2021 Jul 16;6(3):e20.00148. doi: 10.2106/JBJS.OA.20.00148. eCollection 2021 Jul-Sep.
- Background: PubMed 34915484Ng ZY, Honeyman C, Lellouch AG, Pandya A, Papavasiliou T. Smartphone-Based DIY Home Microsurgical Training with 3D Printed Microvascular Clamps and Japanese Noodles. Eur Surg Res. 2023;64(2):301-303. doi: 10.1159/000521439. Epub 2021 Dec 15.
- 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.
Samuel Poore, MD, PhD principal investigator
UW School of Medicine and Public Health
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 Procedure, Unspecified, run by University of Wisconsin, Madison at 1 site in United States.
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 2 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 5 Jun 2025. 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 United States. 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?
Time to Perform Anastomosis (time frame: up to 30 min). The study lists 3 primary outcomes in all. 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 NCT07006766, which also lists 3 linked publications.
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 5 Jun 2025.