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Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. By the invented and adopted energy surgical instruments, surgical procedure is safer and easier than before. The newly surgical instruments reduce the post-operative mortality and morbidity combined easy procedures of surgery. As the most popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar electrocautery were received lots of attention and concern. Some studies have shown some advantage of the two instruments, which were they can facilitate the surgical treatment and make the surgery safer and more effective. Although, some small retrospective sample reports claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node intraoperative complications and even postoperative complications. And Korea small sample randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and surgical duration. However, postoperative complications were with no statistical significance between the two instruments. Cost- effective analysis of the energy instruments is still controversial. Large sample randomized control trail with high quality is needed.
By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from North to South in China aims to compare the clinical characteristics and outcomes, when using of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative complications, cost data, and post-operative quality of life.
Standard Operating Procedure (SOP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic scalpel surgery group | Experimental | During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock. |
|
| Monopolar electrocautery surgery group | Experimental | During the procedures of the abdominal approach D2 distal gastrectomy, use monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monopolar electrocautery | Device | During the procedures of the abdominal approach D2 distal gastrectomy, use the monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes . |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical duration | From the skin incision to finish the suture of abdominal wall | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | The intraoperative blood loss | Intraoperative |
| Number of harvested and positive lymph nodes | Number of harvested and positive lymph nodes by pathological results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Kun Hu, M.D.,Ph.D. | Contact | +8618980601504 | hujkwch@126.com | |
| Wei-Han Zhang, M.D. | Contact | +8613438919160 | weihanwch@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-Kun Hu, Ph.D., M.D. | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital and Institute | Recruiting | Beijing | Beijing Municipality | 10000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38000074 | Derived | Wu J, Wang H, Yin X, Wang Y, Lu Z, Zhang J, Zhang Y, Xue Y. Normalization weighted combination scores re-evaluate TNM staging of gastric cancer: a retrospective cohort study based on a multicenter database. Int J Surg. 2024 Jan 1;110(1):11-22. doi: 10.1097/JS9.0000000000000726. |
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| Ultrasonic scalpel | Device | During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes |
|
| Postoperative |
| Intraoperative Mortality and Morbidity | Evaluation the intraoperative mortality and morbidity | Intraoperative |
| Survival outcome | the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate | 3 years |
| Postoperative Mortality and Morbidity | Evaluation the postoperative (30 days) mortality and morbidity | Postoperative (30 days) |
| Guangdong General Hospital | Not yet recruiting | Guangzhou | Guangdong | 51000 | China |
|
| The Third Affiliated Hospital, Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
|
| Union Hospital, Tongji Medical College | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shengyang | Liaoning | 110001 | China |
|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Zhongshan Hospital, Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D016063 | Blood Loss, Surgical |
| 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 |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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