Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.
详细描述
As above.
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 80 Years（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 the listed minimally invasive surgical procedures for treatment of respective diseases
- •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)
- •Robotic Colorectal Resection
- •Inclusion Criteria:
- •Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery
- •Exclusion Criteria:
- •Recurrent tumor
- •Extensive previous abdominal surgery precluding minimally invasive surgery
- •Robotic Transanal Total Mesorectal Excision
- •Inclusion Criteria:
- •Mid/low rectal adenocarcinoma located <12 cm from the anal verge
- •Exclusion Criteria:
- •T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
- •Tumor requiring multivisceral resection
- •Tumor requiring abdominoperineal resection; recurrent rectal tumor
- •T1 tumor that can be treated by local excision
- •Extensive previous abdominal surgery
- •Robotic Rectopexy
- •Inclusion Criteria:
- •Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
- •Exclusion Criteria:
- •Extensive previous abdominal surgery precluding minimally invasive surgery
- •Radical Prostatectomy
- •Inclusion Criteria:
- •Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
- •Exclusion Criteria:
- •Previous history of prostate surgery (e.g., transurethral resection of prostate)
- •Total or Partial Nephrectomy
- •Inclusion Criteria:
- •Clinically diagnosed with nonmetastatic kidney cancer
- •Exclusion Criteria:
- •Previous ipsilateral kidney surgery
- •Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)
- •Radical Cystectomy
- •Inclusion Criteria:
- •Clinically diagnosed with nonmetastatic bladder cancer
- •Robotic Esophageal Hiatal Surgery and Fundoplication
- •Inclusion Criteria:
- •Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication
- •Exclusion Criteria:
- •Previous history of laparotomy precluding minimally invasive surgery
- •Robotic Gastrectomy
- •Inclusion Criteria:
- •Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy
- 另有 13 项未显示
结局指标
主要结局
Conversion rate
时间窗: Up to 1 month
The definition of a conversion for this study is an emergent change in the treatment plan to conventional minimally invasive (laparoscopic/thoracoscopic) 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
Perioperative 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. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.
次要结局
- Operative time(Up to 1 month)
- Operative 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)
- Resection margin positivity for malignancy(Up to 1 month)
- Number of lymph nodes harvested(Up to 1 month)
- Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)(Up to 12 months)
- Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)(Up to 12 months)
- Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS)(Up to 12 months)
研究者
Simon S. M. Ng
Wei Lun Professor of Surgery
Chinese University of Hong Kong