Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioabsorbable Staple Line Reinforcement configured for circular staplers | Experimental | stomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple |
|
| anastomotic staple line without reinforcement | Active Comparator | stomach, colorectal and lung anastomotic staple line without reinforcement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioabsorbable Staple Line Reinforcemen | Device | cingular Bioabsorbable Staple Line Reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Experience a hemorrage | The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure. | 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak | The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 1-3 months post procedure. | 1-3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| study director | Contact | 02138016387 | july_s@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital affiliated to Shanghai jiaotong Uni school of medicine | Recruiting | Shanghai | China |
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
with a bioabsorbable staple line reinforcement material compared with standard non-reinforced material
Not provided
Not provided
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |