Colorectal Neoplasms Clinical Trial
Official title:
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES)
are emerging minimally invasive surgery techniques which can further reduce patient trauma
and enhance recovery. However, the wider adoption of these techniques is hampered by the
limitation of instrumentation and technical difficulties. Robotic assistance may improve
surgical capabilities during single port surgery and NOTES by providing augmented motion
precision and manipulation dexterity.
Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES
(mainly transanal and transoral surgery) using a novel single port robotic system.
Design: Prospective, single center, multispecialty study consistent with a stage 1
(Innovation) study described in the Innovation, Development, Exploration, Assessment,
Long-term Study (IDEAL) framework.
Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for
single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the
inclusion and exclusion criteria will be recruited.
Intervention: Single port surgery and transanal/transoral surgery will be performed using the
novel single port robotic system.
Study Endpoints: Primary: conversion rate and perioperative complications. Secondary:
operative time, blood loss, pain scores, analgesic requirement, and length of stay.
Hypothesis: The prospective study will provide important information on the feasibility,
safety, and effectiveness of the novel single port robotic system in performing single port
surgery and NOTES in various surgical specialties. A positive study will provide supporting
evidence for continuing development of this new technology.
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