Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Cingularbio Co. Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bioabsorbable Staple Line Reinforcemen
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai Cingularbio Co. Ltd
Lead sponsor
RenJi Hospital
Collaborator
Source ClinicalTrials.gov