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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracorporeal Roux-en-Y esophagojejunostomy | Experimental | During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVilâ„¢) will be performed for the patients assigned to this arm. |
|
| Extracorporeal Roux-en-Y esophagojejunostomy | Active Comparator | During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracorporeal Roux-en-Y esophagojejunostomy | Procedure | During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVilâ„¢) will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis-related early complication rate | Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reconstruction time | Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed. Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed. | During operation |
| Morbidity and mortality rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxin Li, M.D., Ph.D. | Contact | +86-138-0277-1450 | gzliguoxin@163.com | |
| Yanfeng Hu, M.D | Contact | +86-136-3249-4551 | huyanfenger@vip.tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoxin Li, M.D., Ph.D. | Nanfang Hospital, Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510-515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21993942 | Background | Marangoni G, Villa F, Shamil E, Botha AJ. OrVil-assisted anastomosis in laparoscopic upper gastrointestinal surgery: friend of the laparoscopic surgeon. Surg Endosc. 2012 Mar;26(3):811-7. doi: 10.1007/s00464-011-1957-x. Epub 2011 Oct 13. | |
| 19343421 | Background | Jeong O, Park YK. Intracorporeal circular stapling esophagojejunostomy using the transorally inserted anvil (OrVil) after laparoscopic total gastrectomy. Surg Endosc. 2009 Nov;23(11):2624-30. doi: 10.1007/s00464-009-0461-z. Epub 2009 Apr 3. |
| Label | URL |
|---|---|
| Southern Medical University, China | View source |
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| Extracorporeal Roux-en-Y esophagojejunostomy | Procedure | During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed. |
|
The early postoperative complication was defined as the event observed within 30 days after surgery. |
| 30 days |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course. | 2 weeks |
| Postoperative quality of life | EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery. | 6 months |
| 20953884 | Background | Kunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17. |
| 23211117 | Background | Jeong O, Jung MR, Kim GY, Kim HS, Ryu SY, Park YK. Comparison of short-term surgical outcomes between laparoscopic and open total gastrectomy for gastric carcinoma: case-control study using propensity score matching method. J Am Coll Surg. 2013 Feb;216(2):184-91. doi: 10.1016/j.jamcollsurg.2012.10.014. Epub 2012 Dec 2. |
| Nanfang Hospital, China | View source |
| Chinese Anti-Cancer Association | View source |
| 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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