Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Recruiting · NCT06968221 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Cingularbio Co. Ltd
View the official record on ClinicalTrials.gov →Interventions studied
Bioabsorbable Staple Line Reinforcemen
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Renji hospital affiliated to Shanghai jiaotong Uni school of medicine - Shanghai, China