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The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.
A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4K Laparoscopic Surgery | Experimental | 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
|
| HD Laparoscopic Surgery | Active Comparator | HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4K Laparoscopic Surgery | Procedure | 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| operating time | day | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The number of lymph node dissection | number | 1 day |
| the number of positive lymph nodes | the number of positive lymph nodes | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changming Huang Huang | Fujian Medical University Union Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | 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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| HD Laparoscopic Surgery | Procedure | HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. |
|
| intraoperative lymph node dissection time | (regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node) | 1 day |
| intracavitary anastomosis time | (patients who undergo totally laparoscopic surgery are analyzed) | 1 day |
| intraoperative blood loss | ml | 1 day |
| intraoperative injury | intraoperative injury | 1 day |
| the amount of use of titanium clip | the amount of use of titanium clip | 1 day |
| the rate of conversion to laparotomy | the rate of conversion to laparotomy | 1 day |
| Time to first ambulation | Time to first ambulation | 10 days |
| Time to first flatus | Time to first flatus | 10 days |
| Time to first liquid diet | Time to first liquid diet | 10 days |
| Time to first soft diet | Time to first soft diet | 10 days |
| duration of postoperative hospital stay | duration of postoperative hospital stay | 10 days |
| Complication | (early complications occurred within 30 days after operation): pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; long term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome | 30 days;36 months |
| The daily highest body temperature before discharge | The daily highest body temperature before discharge | 7 days |
| Overall postoperative morbidity and mortality rates | The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions. Postoperative morbidities are divided into short-term and long-term complications after surgery. Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days. Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation. Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery. | 30 days |
| Hospitalization expenses | dolloars | 1 months |
| 3-year disease free survival rate | month | 36 months |
| 3-year overall survival rate | month | 36 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |