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The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Experimental | The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. |
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| Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Active Comparator | The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction | Procedure | In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative recovery results | Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) | Within 1 month after surgery |
| Late postoperative recovery results | Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) | 1 year after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc | Within 1 month after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyu Deng, M.D. | Contact | +86-22-23340123 | dengery@126.com | |
| Han Liang, M.D. | Contact | +86-22-23340123 | tjlianghan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Tianjin Medical University | Recruiting | Tianjin | 300060 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2020 | Feb 26, 2021 |
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|
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2020 | Feb 26, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2020 | Feb 26, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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