A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery

The Chinese University of Hong Kong

Status: Completed

Conditions: Hypopharyngeal Neoplasms; Oropharyngeal Neoplasms; Oral Neoplasms; Laryngeal Neoplasms; ENT Diseases; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Urologic Diseases; Urologic Neoplasms

Treatments: Procedure: Robotic single port surgery and NOTES

Study type: Interventional

Funder types: Other

Identifiers

NCT03010813

CREC Ref. No.: 2016.348

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES

1. Body mass index <35 kg/m2
2. Suitable for minimally invasive surgery
3. Willingness to participate as demonstrated by giving informed consent

GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES

1. Contraindication to general anesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Noncorrectable coagulopathy
5. Presence of another malignancy or distant metastasis
6. Emergency surgery
7. Vulnerable population (e.g. mentally disabled, pregnancy)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Novel single port robotic system

Experimental group

Description:

A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula

Treatment:

Procedure: Robotic single port surgery and NOTES