Overview
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.
Description
This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.
Eligibility
Inclusion Criteria:
- Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
- Subjects willing to accept informed consent and willing to attend the follow up
Exclusion Criteria:
- Subjects who have significant intraoperative hypotension or cardiac events.
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).
- Subjects have uncontrolled intra-abdominal infection