aparoscopic versus Open Gastrectomy: a multicenter randomized controlled trial
- Conditions
- Gastric Cancer, Gastrectomy, LaparoscopyMaagkanker, Maagresectie, Laparoscopie
- Registration Number
- NL-OMON21049
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. PubMed PMID: 15761078 <br><br> 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. Epub 2004 Apr 13. PubMed PMID: 15082726 <br><br> Ronellenfitsch U, Schwarzbach M, Hofheinz R, Kienle P, Kieser M, Slanger TE, Jensen K; GE Adenocarcinoma Meta‐analysis Group. Perioperative chemo(radio)therapy versus primary surgery for resectable adenocarcinoma of the stomach, gastroesophageal junction, and lower esophagus. Cochrane Database Syst Rev. 2013 May 31;5:CD008107. doi: 10.1002/14651858.CD008107.pub2. Review. PubMed PMID: 23728671 <br><br> Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. PubMed PMID: 21573742 <br><br> Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP, van Hillegersberg R. Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1509-20. doi: 10.1007/s00464-012-2661-1. Epub 2012 Dec 14. Review. PubMed PMID: 23263644 <br><br> Dicken BJ, Bigam DL, Cass C, Mackey JR, Joy AA, Hamilton SM. Gastric adenocarcinoma: review and considerations for future directions. Ann Surg. 2005 Jan;241(1):27-39. Review. PubMed PMID: 15621988 <br><br> Griffin SM. Gastric cancer in the East: same disease, different patient. Br J Surg. 2005 Sep;92(9):1055-6. PubMed PMID: 16106468 <br><br> Fein M, Fuchs KH, Thalheimer A, Freys SM, Heimbucher J, Thiede A. Long-term benefits of Roux-en-Y pouch reconstruction after total gastrectomy: a randomized trial. Ann Surg. 2008 May;247(5):759-65. doi: 10.1097/SLA.0b013e318167748c. PubMed PMID: 18438112 <br><br> Shim JH, Oh SI, Yoo HM, Jeon HM, Park CH, Song KY. Roux-en-Y Gastrojejunostomy After Totally Laparoscopic Distal Gastrectomy: Comparison With Billorth II Reconstruction. Surg Laparosc Endosc Percutan Tech. 2014 Apr 4. [Epub ahead of print] PubMed PMID: 24710243 <br><br> Lee JH, Lee HJ, Kong SH, Park do J, Lee HS, Kim WH, Kim HH, Yang HK. Analysis of the lymphatic stream to predict sentinel nodes in gastric cancer patients. Ann Surg Oncol. 2014 Apr;21(4):1090-8. doi: 10.1245/s10434-013-3392-9. Epub 2013 Nov 26. PubMed PMID: 24276637 <br><br> Mortensen K, Nilsson M, Slim K, Schäfer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; the Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Br J Surg. 2014 Jul 21. doi: 10.1002/bjs.9582. [Epub ahead of print] PubMed PMID: 25047143 <br><br> Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. PubMed PMID: 15273542 <br><br> Haverkamp L, Ruurda JP, van der Sluis PC, van Hillegersberg R. [Surgical treatment of gastric cancer: focus on centralisation and laparoscopic resections]. Ned Tijdschr Geneeskd. 2013;157(35):A5864. Review. Dutch. PubMed PMID: 23985239
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 210
• Histologically proven adenocarcinoma of the stomach
• Surgically resectable (cT1-4a, N0-3b, M0) tumor
Exclusion criteria
• Siewert type I esophago-gastric junction tumor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospital stay
- Secondary Outcome Measures
Name Time Method Post-operative morbidity <br /><br>Mortality <br /><br>Readmissions<br /><br>Oncologic outcome<br /><br>Quality of life<br /><br>Cost-effectiveness