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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.
As above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic surgery using the Sentire Surgical System | Experimental | Robotic surgery using the Sentire Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic surgery using the Sentire Surgical System | Procedure | Robotic surgery using the Sentire Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | 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. | Up to 1 month |
| Perioperative complications | 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. | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Up to 1 month | |
| Operative blood loss | Up to 1 month | |
| Pain scores on a visual analog scale |
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General Inclusion Criteria for All Procedures:
General Exclusion Criteria for All Procedures:
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:
Robotic Transanal Total Mesorectal Excision
Inclusion Criteria:
- Mid/low rectal adenocarcinoma located <12 cm from the anal verge
Exclusion Criteria:
Robotic Rectopexy
Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon SM Ng, MD | Contact | +852-35051495 | simonng@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Simon SM Ng, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Recruiting | Hong Kong | China |
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| 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) | The Cleveland Clinic Incontinence Score or Wexner's Score is the most common score used to determine the severity of incontinence before and after surgery for anal incontinence. The scoring system takes into account the type and frequency of incontinence, and the extent to which it alters the patient's life. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that may range from 0 to 20. Higher scores indicate higher levels of incontinence. | Up to 12 months |
| Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire) | IIEF-5 is an abridged five-item version of the 15-item International Index of Erectile Function (IIEF) which is used to diagnose the presence and severity of erectile dysfunction. This questionnaire consists of only five questions and each IIEF-5 item is scored on a five-point ordinal scale where lower values represent poorer sexual function. Thus, a response of 0 for a question is considered the least functional, whereas a response of 5 is considered the most functional. The possible scores for the IIEF-5 range from 1 to 25 (one question has scores of 1-5), and a score above 21 is considered as normal erectile function and at or below this cutoff, erectile dysfunction. | Up to 12 months |
| Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS) | IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). | Up to 12 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012005 | Rectal Prolapse |
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D001749 | Urinary Bladder Neoplasms |
| D007680 | Kidney Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| D004938 | Esophageal Neoplasms |
| D042882 | Gallstones |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D007674 | Kidney Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D013272 | Stomach Diseases |
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