The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.
Subject is competent and willing to provide documented informed consent to participate in this clinical study
Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
Subject is ≥ 18 years of age at time of consent
Subject is unable or unwilling to comply with the study requirements or follow-up schedule
Subject with ASA classification ≥ IV
Subject is pregnant (as determined by standard site practices)
The procedure is an emergency procedure
Single group
Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
DeviceSignia™ Circular Stapling system used for the creation of an anastomosis
Incidence of anastomotic leak
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 leaks
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.
Clinical significance of anastomotic leaks
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.
Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.
Incidence of anastomotic bleeding
bleeding at the anastomotic site that requires endoscopic or surgical intervention
Surgeon satisfaction
Surgeon satisfaction via a questionnaire
Incidence of serious device-related adverse events
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: 1. Death, 2. Serious deterioration in the health of the subject, users or other persons as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function including chronic diseases, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, or 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment.
Clavien-Dindo classification of surgical complications
Clavien-Dindo classification of postoperative device related adverse events and serious device related adverse events.
Readmission to hospital
Readmission to hospital for study index procedure-related complications
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