Benign or Malignant Rectal or Colon Tumors, Colorectal Cancer
Conditions
Brief summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Detailed description
Primary Performance: * The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion\* to an alternate approach comprises conversion to open, multiport laparoscopic\*\*, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. * Performing an extracorporeal anastomosis is not considered a conversion \*\* Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance Primary Safety: • The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Interventions
DEVICERobotic Assisted Surgery
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision
Sponsors
Intuitive Surgical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * BMI ≤ 35 * Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures * ASA ≤ 3 * Willing and able to provide a written informed consent document * Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years
Exclusion criteria
* Clinical or radiological evidence of metastatic disease * Life expectancy less than 6 months * Cancer of the anal canal requiring an abdominoperineal resection * Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY) * Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case * Subjects undergoing both LAR/TME and right colectomy during the same operation * Preoperative colonoscopy demonstrating synchronous colorectal cancer * History of inflammatory bowel disease * Subject has a known bleeding or clotting disorder * Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Subject is contraindicated for general anesthesia or surgery * Subject had prior incisional hernia with mesh repair * Subject belongs to vulnerable population * Subject is pregnant or suspected to be pregnant Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Conversion | IntraOperative period | Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. |
| Major Adverse Events Rates | Intraoperative through the 42-day postoperative period | Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period |
Countries
South Korea, United States
Contacts
STUDY_DIRECTORMadhu L Gorrepati
Clinical Affairs Director
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Lower Anterior Resection (LAR) | 54.4 years STANDARD_DEVIATION 12.71 |
| Age, Continuous Right Colectomy (RC) | 64.4 years STANDARD_DEVIATION 13.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment South Korea | 20 participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 1 / 28 | 0 / 29 |
| serious Total, serious adverse events | 2 / 28 | 5 / 29 |
Outcome results
None listed