Clinical trial · Interventional
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Stage III | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer Stage III | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioabsorbable Staple Line Reinforcemen | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bioabsorbable Staple Line Reinforcement configured for circular staplers
- description
- stomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple
- interventionNames
- Device: Bioabsorbable Staple Line Reinforcemen
- type
- ACTIVE_COMPARATOR
- label
- anastomotic staple line without reinforcement
- description
- stomach, colorectal and lung anastomotic staple line without reinforcement
- interventionNames
- Device: Bioabsorbable Staple Line Reinforcemen
Primary outcomes (1)
- measure
- Proportion of Subjects Who Experience a hemorrage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available