Clinical trial NCT07006766: Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
Official title: Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Keywords: microsuture
microsurgery
surgical training
microsurgical education
global
accessibility
noodle
synthetic
vessel
anastomosis
patency
education
outreach
low-cost
microsurgical simulation
simulation
vessel simulator
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical residents or individual with no formal microsurgical education.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participant is unable to commit 1-2 hours to the study.

Primary outcomes:
measure: Time to Perform Anastomosis
timeFrame: up to 30 min
measure: Number of Stitches
timeFrame: up to 30 min
measure: Patency (either Yes or No)
timeFrame: up to 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Samuel Poore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mohammad 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.
citation: Ng 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.