Colorectal Adenoma and Carcinoma
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 Surgical System C1000 had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal surgery. Recently, a new component of the system - the Patient Side Single Arm, is developed. It is an independent robotic arm designed for compatibility with the Sentire Surgical System, creating the hybrid surgical system known as the C1000 Ultra. The new component may enhance port placement flexibility, minimize arm collisions with the patient or operating table, and optimize docking for seamless integration into the operating room. The Patient Side Single Arm was proven by a preclinical study using cadaveric models to be safe and effective. The investigators would therefore like to conduct a prospective clinical study to evaluate the efficacy and safety of Sentire Surgical System Plus the Patient Side Single Arm in robotic colorectal surgery. The investigators believe that the results of this study will provide data to support its use for wide range of colorectal procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical applications for minimally invasive surgery with a cost-effective model.
Interventions
PROCEDURERobotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
Robotic surgery using the Sentire Surgical System Plus Patient Side Single Arm
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 No maximum
Healthy volunteers
No
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 * Body mass index \<35 kg/m2 * Willingness to participate as demonstrated by giving informed consent
Exclusion criteria
* T4 tumor * Recurrent tumor * Extensive previous abdominal surgery precluding minimally invasive surgery * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | Up to 1 month | The definition of a conversion for this study is an emergent or unplanned change in the treatment plan to conventional laparoscopic or 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 | Perioperative | — |
| Operative blood loss | Perioperative | — |
| Pain scores on visual analog scale | Up to 1 month | Pain scores on visual analog scale range from 0 which implies no pain at all, to 100 which implies the worst pain imaginable. |
| Analgesic requirement | Up to 1 month | Total doses of paracetamol and tramadol used postoperatively. |
| Length of hospital stay | Up to 1 month | — |
| Completeness of resection | Up to 1 month | Completeness of total mesorectal excision (TME) is classified as complete, nearly complete, or incomplete based on gross pathologic assessment. Complete TME is defined as intact mesorectum with only minor irregularities of a smooth mesorectal surface; no defect is deeper than 5 mm; no coning toward the distal margin; and smooth circumferential resection margin (CRM) on slicing. Nearly complete TME is defined as moderate bulk to the mesorectum; irregularity of the mesorectal surface; moderate coning of the specimen; and lack of visibility of the muscularis propria visible at any site, with the exception of the insertion of the levator muscles. Incomplete TME is defined as little bulk to mesorectum with defects down onto muscularis propria and/or very irregular CRM. |
| Resection margin positivity for malignancy | Up to 1 month | A circumferential resection margin \<1mm is defined as positive; a distal resection margin \<1 mm is defined as positive. |
| Number of lymph nodes harvested | Up to 1 month | — |
Countries
China
Contacts
CONTACTSimon SM Ng, MD
CONTACTKaori Futaba, MD
Outcome results
None listed