A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Robotic single port surgery and NOTES (Procedure)
结局指标
主要结局
Conversion rate
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong