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The main purpose of this study is to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Surgical resection is the mainstay of treatment for gastric cancer. The extent of surgical resection includes total or subtotal gastrectomy, D2 lymphadenectomy, and prophylactic or therapeutic resection of the surrounding organs or tissues (e.g., omentum, peritoneum, etc). However, the oncologic importance of omentectomy during gastrectomy remains unclear. The European guidelines do not give any advice regarding omentectomy, whereas the most recent American guidelines advise to resect both the greater and lesser omentum. Alternatively, the Japanese gastric cancer treatment guidelines recommends preservation of the greater omentum at >3 cm from the gastroepiploic arcade for patients with T1-T2 tumors and total omentectomy for patients with T3-T4 tumors. In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, and postoperative morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | D2 radical gastrectomy with partial omentectomy |
|
| Control group | No Intervention | D2 radical gastrectomy with total omentectom |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of omentectomy | Procedure | Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 years relapse-free survival | Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5 years overall survival | Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The volume of intraoperative blood loss | The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters. | 1 week |
| The length of the operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Liang, Master | Contact | +86 022 23340123 | 1061 | tjlianghan@126.com |
| Bin Ke, Doctor | Contact | +86 13622036809 | binke@tmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Han Liang, Master | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | 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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The length of the operation was defined as the time from first skin incision to wound closure. The length of the operation is recorded in minutes. |
| 1 week |
| Postoperative hospital stay | Postoperative hospital stay was defined as the time from the date of operation to the date of discharge. The postoperative hospital stay is recorded in days. | 3 months |
| Postoperative morbidity | Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications. | 1 month |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |