Anastomotic Complication, Anastomotic Leak, Anastomotic Leaks, Colonic Diseases, Colorectal Anastomosis, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Left-sided Colon Resection, Postoperative Complications, Rectal Diseases
Conditions
Keywords
Colorectal Anastomosis, Left-sided Colon Resection, Circular stapler, Anastomotic Leak, Rectal cancer, Low anterior resection, Powered stapler
Brief summary
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.
Detailed description
The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections. The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.
Interventions
DEVICESignia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
Signia™ Circular Stapling system used for the creation of an anastomosis
Sponsors
Medtronic - MITG
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
Preoperative Inclusion Criteria: 1. Subject is competent and willing to provide documented informed consent to participate in this clinical study 2. 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 3. Subject is ≥ 18 years of age at time of consent Preoperative
Exclusion criteria
1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule 2. Subject with ASA classification ≥ IV 3. Subject is pregnant (as determined by standard site practices) 4. The procedure is an emergency procedure 5. The procedure is a revision/reoperation for the same indication 6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months 7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study 8. Subject will undergo multiple synchronous colon resections 9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed) 10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure 11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure) 12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure) 13. Any subject undergoing an ileal-anal pouch anastomosis surgery Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anastomotic leak | within 30 days, +/- 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anastomotic leaks | within 90 days, +/- 14 days | 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 | within 90 days, +/- 14 days | 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) | Day 0 (day of surgery) | Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. |
| Incidence of anastomotic bleeding | within 30 and 90 days, +/- 14 days | bleeding at the anastomotic site that requires endoscopic or surgical intervention |
| Incidence of device-related adverse events | within 90 days, +/- 14 days | 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 | discharge (post-surgery up to 90 days, +/- 14 days) | 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 | within 90 days, +/- 14 days | Incidence of re-operation or surgical intervention due to an adverse event related to the Signia™ circular stapler or accessory components |
Countries
United States
Contacts
CONTACTYeshareg Yismaw
CONTACTStudy Mailbox
PRINCIPAL_INVESTIGATORKatharine Louise Jackson, MD, FACS, MBBS, MA
Duke Raleigh Hospital
PRINCIPAL_INVESTIGATORJohn Monson, MD, FACS
Northwell Health
Outcome results
None listed