Bladder Cancer, Colorectal Carcinoma, Esophageal Cancer, Gallstones, Gastric Cancer, GIST - Gastrointestinal Stromal Tumor, Hiatal Hernia With Gastroesophageal Reflux Disease, Kidney Cancer, Prostate Cancer (Adenocarcinoma), Rectal Prolapse
Conditions
Brief 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.
Detailed description
As above.
Interventions
PROCEDURERobotic surgery using the Sentire Surgical System
Robotic surgery using the Sentire Surgical System
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Resection margin positivity for malignancy | Up to 1 month | — |
| Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score) | Up to 12 months | 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. |
| Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire) | Up to 12 months | 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. |
| Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS) | Up to 12 months | 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). |
| Length of hospital stay | Up to 1 month | — |
| Number of lymph nodes harvested | Up to 1 month | — |
Countries
China
Contacts
Primary ContactSimon SM Ng, MD
Outcome results
None listed