Colorectal CarcinomaRectal ProlapseProstate Cancer (Adenocarcinoma)Bladder CancerKidney CancerHiatal Hernia With Gastroesophageal Reflux DiseaseGIST - Gastrointestinal Stromal TumorEsophageal CancerGallstonesGastric Cancer
Investigational drug(s) / intervention(s)
Robotic surgery using the Sentire Surgical System
Robotic surgery using the Sentire Surgical System: Robotic surgery using the Sentire Surgical System
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
General 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)
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:
* T4 tumor
* 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
Exclusion Criteria:
\- Previous history of laparotomy precluding minimally invasive surgery
Robotic Esophagectomy
Inclusion Criteria:
\- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy
Exclusion Criteria:
\- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy
Robotic Cholecystectomy
Inclusion Criteria:
\- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy
Exclusion Criteria:
* Acute cholecystitis
* Previous history of abdominal surgery
Primary outcome measure(s)
Conversion rate — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
China
Recruiting
More Chinese University of Hong Kong trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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