A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasms
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Conversion rate
- Status
- Completed
- Last Updated
- 8 years ago
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 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.
Investigators
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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
- Operative time(Intraoperative)
- Estimated blood loss(Up to 1 month)
- 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)
- 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)
- 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)