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| Name | Class |
|---|---|
| Shanghai Medical College of Fudan University | UNKNOWN |
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The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.
The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery.
Early postoperative morbidity is classified as follows:
(1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc.
The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLDG arm | Experimental | TLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy. |
|
| LADG arm | Experimental | LADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLDG arm | Procedure | After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative 30-day morbidity rate | Check the morbidity rate :Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc. | Postoperative 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| QOL measurement : EORTC QLQ-C30/STO22 | EORTC QLQ-C30/STO22 | screening(pre op) / Postoperative 30-day,3-month,6-month,12-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499377 | Derived | Zhang Y, Li Z, Tian Y, Yu J, Wang J, Lee C, Wang K, He X, Qiao Q, Ji G, Xu Z, Yang L, Xu H, Du X, Su X, Xing J, Niu Z, Zhu L, Yan S, Li Y, Wang J, Li Z, Zhao Y, You J, Jing C, Fan L, Du Y, Zhao G, Song W, Xuan Y, Zang M, Chen J, Park S, Huang H; China-Korea Laparoscopic Gastrointestinal Surgery Study (CKLASS) Cooperative Group. Morbidity and quality of life of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer: a multi-center prospective randomized controlled trial (CKLASS01). Gastric Cancer. 2025 Jan;28(1):131-144. doi: 10.1007/s10120-024-01561-y. Epub 2024 Nov 5. | |
| 38960885 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 16, 2023 | |
| Reset | Apr 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 16, 2023 | Apr 26, 2024 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between "Totally laparoscopic distal gastrectomy" and "Laparoscopy-assisted distal gastrectomy" in Korea.
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| LADG arm | Procedure | After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG) |
|
| Derived |
| Lee HH, Lee CM, Lee MS, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Son YG, Choi SI, Jung MR, Seo SH, Park SH, Hwang SH, Min JS, Park S. Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial). J Gastric Cancer. 2024 Jul;24(3):257-266. doi: 10.5230/jgc.2024.24.e22. |
| 38716987 | Derived | Park SH, Lee CM, Hur H, Min JS, Ryu SW, Son YG, Chae HD, Jeong O, Jung MR, Choi CI, Song KY, Lee HH, Kim HG, Jee YS, Hwang SH, Lee MS, Kim KH, Seo SH, Jeong IH, Son MW, Kim CH, Yoo MW, Oh SJ, Kim JG, Hwang SH, Choi SI, Yang KS, Huang H, Park S. Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07: a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4810-4820. doi: 10.1097/JS9.0000000000001543. |
| 30845995 | Derived | Lee CM, Park JH, In Choi C, Lee HH, Min JS, Jee YS, Jeong O, Chae H, Choi SI, Huang H, Park S. A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol). BMC Cancer. 2019 Mar 7;19(1):206. doi: 10.1186/s12885-019-5396-8. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |