Perianal Operating Scope Feasibliity

Study Overview
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Brief Summary
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This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.

Detailed Description
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Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.

Official Title
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Perianal Operating Scope Feasibility

Conditions
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Transanal Endoscopic Surgery

Intervention / Treatment
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* Device: Perianal access device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18 to 80 In good health status Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses Exclusion Criteria: Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions. Patients considerable unsuitable for inclusion in the study by their colorectal surgeon. Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure. Patients with known rectosigmoid infections. Patients with known rectosigmoid wall fragility. Patients with known rectosigmoid perforations.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perianal access device<br> | Device: Perianal access device<br>* Perianal access device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of operative field dimensions measured in centimeters | The Outcome Measure Title implies the visual measurement that will be used to describe the potential operative field delineated by our experimental perianal access device. The description will, therefore, be primarily a qualitative visual assessment with the addition of estimated dimensions measured in centimeters for the length of the longitudinal and transverse fields encompassed by the blades of the access device. The collected measurement data will be aggregated, the numerical data averaged, and the visual perceptions integrated. The Time Frame for the individual study of each insertion will be two minutes or less. There is no chronic component to this feasibility analysis. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perianal surgery