| Eligibility |
Inclusion Criteria:
- The subject must be 18 years of age or older at the time of consent
- Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon
or rectal disease, where SureForm™Staplers are utilized for transection and/or
creation of anastomosis
Exclusion Criteria:
- Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
- Subject with active bacterial or fungal infection
- Subject is contraindicated for general anesthesia or surgery
- Subject is undergoing an emergency procedure
- Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral
hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
- Subject has metastatic disease and/or subject has life expectancy of less than 1 year
- Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant
patient, steroid requirement) within 30 days prior to the planned surgical procedure
- Subject has history of coagulation or hematologic disorder
- Pregnant or suspect pregnancy
- The subject is unable to comply with the follow-up visit schedule
- Subject has perforated, obstructing or locally invasive neoplasm (T4b)
- Subject with inflammatory bowel disease
- Subject is mentally handicapped or has a psychological disorder or severe systemic
illness that would preclude compliance with study requirements or ability to provide
informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Intra-Operative Exclusion Criteria:
- Subjects who require extensive dissection to release adhesions or with advanced cancer
which may result in anastomotic leak and/or bleeding unrelated to the stapler.
- Inadequate visualization making an endoscopic approach not feasible
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
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