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The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).
The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gasless Laparoscopy-assisted Gastrectomy | Experimental | Patients receive Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. |
|
| Conventional Laparoscopy-assisted Gastrectomy | Other | Patients receive Conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy for Distal Gastric Cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Laparoscopy | Device | A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy. | During procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Intraoperative blood pressure | Through study completion, an average of 2 year. |
| End-tidal carbon dioxide | Intraoperative end-tidal carbon dioxide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingwei Xue, doctor | Harbin Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin University Cancer Hospital | Harbin | Heilongjiang | 150086 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Gasless Laparoscopy | Device | A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures. |
|
|
| Through study completion, an average of 2 year. |
| Heart rate | Intraoperative heart rate | Through study completion, an average of 2 year. |
| Estimated blood loss | Intraoperative estimated blood loss | Through study completion, an average of 2 year. |
| Complications | Intraoperative complications | Through study completion, an average of 2 year. |
| Death | Intraoperative death | Through study completion, an average of 2 year. |
| Blood transfusion | Intraoperative and postoperative blood transfusion | Through study completion, an average of 2 year. |
| Tumor size | Tumor size | Through study completion, an average of 2 year. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |