Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis.

Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis.

Anastomotic leaks graded according to International Study Group of Rectal Cancer (ISGRC):

Grade A: Anastomotic leakage results in no change in patients' management. Grade B: Leakage requires active therapeutic intervention but is manageable without re-laparotomy/operative intervention*.

Grade C: Anastomotic leakage requires re-laparotomy/operative intervention*.

*Operative intervention was added to the ISGRC definition for the purpose of this study.

Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.

bleeding at the anastomotic site that requires endoscopic or surgical intervention

Adverse events related to Signia™ circular stapler and accessory components. An adverse event is defined as "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated."

Length of hospital stay for the index procedure (from admission to discharge) after the Signia™ circular stapler was used in subjects undergoing left sided colon, sigmoid, or rectal resections

Incidence of re-operation or surgical intervention due to an adverse event related to the Signia™ circular stapler or accessory components

Surgeon satisfaction via a questionnaire

serious device-related adverse events related to Signia™ circular stapler and accessory components. A serious adverse event is defined as an "Adverse event that led to any of the following:

• Death,
• Serious deterioration in the health of the subject, users or other persons as defined by one or more of the following:

• a life-threatening illness or injury, or
• a permanent impairment of a body structure or a body function including chronic diseases, or
• in-patient or prolonged hospitalization, or
• medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, or
• foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment.

Clavien-Dindo classification of postoperative device related adverse events and serious device related adverse events.

Readmission to hospital for study index procedure-related complications