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| Name | Class |
|---|---|
| Guang'an Central Hospital | UNKNOWN |
| Pengan County People's Hospital | OTHER |
| Yilong County people's Hospital | UNKNOWN |
| Nanbu Hospital of County Chinese Medicine |
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This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapler Reinforcement Patch Group | Experimental | Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. |
|
| Standard Stapler Group | Active Comparator | Participants in this group will receive gastrojejunostomy with the use of standard staplers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapler Reinforcement Patch | Device | Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Anastomotic Leakage | The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy. | 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Anastomotic Stricture | The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy. | 3 months post-surgery |
| Postoperative Bleeding Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunhong Tian | Recruiting | Nanchong | Sichuan | 637000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D057868 | Anastomotic Leak |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Langzhong People's Hospital | UNKNOWN |
Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.
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Participants and outcomes assessors will be blinded to the group assignments. Surgeons will be aware of the group assignments but will not disclose this information to the participants or the outcomes assessors.
| Standard Stapler | Device | Participants in this group will receive gastrojejunostomy with the use of Standard Stapler |
|
The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop. |
| 30 days post-surgery |
| Mortality Rate | The rate of mortality within 30 days post-surgery. | 30 days post-surgery |
| Readmission Rate | Readmission Rate | 3 months post-surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |