A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Conversion rate
Study Overview
Brief Summary
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.
Detailed 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES
- •Body mass index <35 kg/m2
- •Suitable for minimally invasive surgery
- •Willingness to participate as demonstrated by giving informed consent
Exclusion Criteria
- •FOR ALL PROCEDURES
- •Contraindication to general anesthesia
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Noncorrectable coagulopathy
- •Presence of another malignancy or distant metastasis
- •Emergency surgery
- •Vulnerable population (e.g. mentally disabled, pregnancy)
Arms & Interventions
Novel single port robotic system
A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula
Intervention: Robotic single port surgery and NOTES (Procedure)
Outcomes
Primary Outcomes
Conversion rate
Time Frame: Up to 1 month
An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery
Perioperative complications
Time Frame: Up to 1 month
Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
Secondary Outcomes
- Completeness of resection(Up to 1 month)
- Resection margins(Up to 1 month)
- Number of lymph nodes harvested(Up to 1 month)
- Anal continence after transanal surgery(Up to 1 year)
- Fecal incontinence quality of life after transanal surgery(Up to 1 year)
- Urinary continence after radical prostatectomy(Up to 1 year)
- Male sexual function after radical prostatectomy(Up to 1 year)
- Operative time(Intraoperative)
- Estimated blood loss(Up to 1 month)
- Renal function after nephrectomy(Up to 1 year)
- Swallowing function after transoral robotic surgery (TORS)(Up to 1 year)
- Voice function after TORS(Up to 1 year)
- Pain scores on a visual analog scale(Up to 1 month)
- Analgesic requirement(Up to 1 month)
- Length of hospital stay(Up to 1 month)
Investigators
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong