Perianal Operating Scope Feasibliity

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Transanal Endoscopic Surgery

Treatments

Device: Perianal access device

Study type

Interventional

Funder types

Other

Identifiers

NCT02807792

1601M83061

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.