Perianal Operating Scope Feasibliity

Not Applicable

Withdrawn

• Conditions: Transanal Endoscopic Surgery
• Interventions: Device: Perianal access device

• Registration Number: NCT02807792
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Study Start: 2017-07
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perianal access device	Perianal access device	-

Primary Outcome Measures

Name	Time	Method
Visual assessment of operative field dimensions measured in centimeters	Baseline	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States