Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study
NCT ID: NCT01919242
Last Updated: 2019-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10000 participants
OBSERVATIONAL
2013-01-31
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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with morbidity
patients who suffered from any type of morbidity after surgery
gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
without morbidity
patients who did not suffer from any type of morbidity after surgery
gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
Interventions
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gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
Eligibility Criteria
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Inclusion Criteria
* age over 20 years with agree to the study
Exclusion Criteria
* vulnerable subjects (ex. pregnancy, disabled to decide by him or herself, cannot understand the study such as mental retardation or foreigner)
20 Years
90 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
Cuschieri A, Weeden S, Fielding J, Bancewicz J, Craven J, Joypaul V, Sydes M, Fayers P. Patient survival after D1 and D2 resections for gastric cancer: long-term results of the MRC randomized surgical trial. Surgical Co-operative Group. Br J Cancer. 1999 Mar;79(9-10):1522-30. doi: 10.1038/sj.bjc.6690243.
Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J. Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol. 2006 Apr;7(4):309-15. doi: 10.1016/S1470-2045(06)70623-4.
Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
Bonenkamp JJ, Songun I, Hermans J, Sasako M, Welvaart K, Plukker JT, van Elk P, Obertop H, Gouma DJ, Taat CW, et al. Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet. 1995 Mar 25;345(8952):745-8. doi: 10.1016/s0140-6736(95)90637-1.
Cuschieri A, Fayers P, Fielding J, Craven J, Bancewicz J, Joypaul V, Cook P. Postoperative morbidity and mortality after D1 and D2 resections for gastric cancer: preliminary results of the MRC randomised controlled surgical trial. The Surgical Cooperative Group. Lancet. 1996 Apr 13;347(9007):995-9. doi: 10.1016/s0140-6736(96)90144-0.
Degiuli M, Sasako M, Ponti A, Soldati T, Danese F, Calvo F. Morbidity and mortality after D2 gastrectomy for gastric cancer: results of the Italian Gastric Cancer Study Group prospective multicenter surgical study. J Clin Oncol. 1998 Apr;16(4):1490-3. doi: 10.1200/JCO.1998.16.4.1490.
Kodera Y, Sasako M, Yamamoto S, Sano T, Nashimoto A, Kurita A; Gastric Cancer Surgery Study Group of Japan Clinical Oncology Group. Identification of risk factors for the development of complications following extended and superextended lymphadenectomies for gastric cancer. Br J Surg. 2005 Sep;92(9):1103-9. doi: 10.1002/bjs.4979.
Park DJ, Lee HJ, Kim HH, Yang HK, Lee KU, Choe KJ. Predictors of operative morbidity and mortality in gastric cancer surgery. Br J Surg. 2005 Sep;92(9):1099-102. doi: 10.1002/bjs.4952.
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.
Other Identifiers
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4-2012-0800
Identifier Type: -
Identifier Source: org_study_id
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