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Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLDG or LADG | Other | To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLDG or LADG | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative early anastomotic morbidity | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Flatus time | 7 days | |
| Quality of life | estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22 | 30 days |
| Postoperative hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Zang, Associate chief physician | Contact | 13600815361 | fjzangwd@163.com | |
| Wenhao Teng, Doctor | Contact | tengwh@yeah.net |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19263143 | Background | Ikeda O, Sakaguchi Y, Aoki Y, Harimoto N, Taomoto J, Masuda T, Ohga T, Adachi E, Toh Y, Okamura T, Baba H. Advantages of totally laparoscopic distal gastrectomy over laparoscopically assisted distal gastrectomy for gastric cancer. Surg Endosc. 2009 Oct;23(10):2374-9. doi: 10.1007/s00464-009-0360-3. Epub 2009 Mar 5. | |
| 25061537 | Background |
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| 30 days |
| Pain score | 10 days |
| Postoperative inflammation response | using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days | 10 days |
| Nutrition | NRS-2002 and PG-SGA in 30 days | 30 days |
| Han G, Park JY, Kim YJ. Comparison of short-term postoperative outcomes in totally laparoscopic distal gastrectomy versus laparoscopy-assisted distal gastrectomy. J Gastric Cancer. 2014 Jun;14(2):105-10. doi: 10.5230/jgc.2014.14.2.105. Epub 2014 Jun 30. |
| 22004901 | Background | Oki E, Sakaguchi Y, Ohgaki K, Saeki H, Chinen Y, Minami K, Sakamoto Y, Toh Y, Kusumoto T, Maehara Y. Feasibility of delta-shaped anastomoses in totally laparoscopic distal gastrectomy. Eur Surg Res. 2011;47(4):205-10. doi: 10.1159/000332850. Epub 2011 Oct 13. |
| 21561328 | Background | Kim BS, Yook JH, Choi YB, Kim KC, Kim MG, Kim TH, Kawada H, Kim BS. Comparison of early outcomes of intracorporeal and extracorporeal gastroduodenostomy after laparoscopic distal gastrectomy for gastric cancer. J Laparoendosc Adv Surg Tech A. 2011 Jun;21(5):387-91. doi: 10.1089/lap.2010.0515. Epub 2011 May 11. |
| 21424875 | Background | Kim MG, Kim KC, Kim BS, Kim TH, Kim HS, Yook JH, Kim BS. A totally laparoscopic distal gastrectomy can be an effective way of performing laparoscopic gastrectomy in obese patients (body mass index>/=30). World J Surg. 2011 Jun;35(6):1327-32. doi: 10.1007/s00268-011-1034-6. |
| 22403746 | Background | Lee J, Kim D, Kim W. Comparison of laparoscopy-assisted and totally laparoscopic Billroth-II distal gastrectomy for gastric cancer. J Korean Surg Soc. 2012 Mar;82(3):135-42. doi: 10.4174/jkss.2012.82.3.135. Epub 2012 Feb 27. |
| 25395149 | Background | Woo J, Lee JH, Shim KN, Jung HK, Lee HM, Lee HK. Does the Difference of Invasiveness between Totally Laparoscopic Distal Gastrectomy and Laparoscopy-Assisted Distal Gastrectomy Lead to a Difference in Early Surgical Outcomes? A Prospective Randomized Trial. Ann Surg Oncol. 2015;22(6):1836-43. doi: 10.1245/s10434-014-4229-x. Epub 2014 Nov 14. |
| 18256884 | Background | Song KY, Park CH, Kang HC, Kim JJ, Park SM, Jun KH, Chin HM, Hur H. Is totally laparoscopic gastrectomy less invasive than laparoscopy-assisted gastrectomy?: prospective, multicenter study. J Gastrointest Surg. 2008 Jun;12(6):1015-21. doi: 10.1007/s11605-008-0484-0. Epub 2008 Feb 7. |