Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy
NCT ID: NCT02413476
Last Updated: 2015-05-19
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
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2015-05-31
2018-05-31
Brief Summary
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Detailed Description
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Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability.
This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic-assisted Gastrectomy(RAG)
Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.
Robotic-assisted Gastrectomy(RAG)
Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.
Laparoscopic-assisted Gastrectomy(LAG)
Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic-assisted Gastrectomy(LAG)
Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.
Interventions
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Robotic-assisted Gastrectomy(RAG)
Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.
Laparoscopic-assisted Gastrectomy(LAG)
Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.
Eligibility Criteria
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Inclusion Criteria
2. Age:older than 18 years old,younger than 80 years old.
3. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition
4. No obvious surgical contraindications.
5. American Society of Anesthesiology (ASA) score class I, II, or III
6. Written informed consent.
Exclusion Criteria
2. Pregnancy
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
5. History of unstable angina or myocardial infarction within past six months
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of other malignant disease within past 5 years.
8. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
9. Any accompanying surgical condition needed to be performed in the same time
18 Years
80 Years
ALL
No
Sponsors
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wei bo
OTHER
Responsible Party
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wei bo
Vice Director of the general surgery department, Chinese PLA General Hospital
Principal Investigators
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Wei bo, MD
Role: STUDY_CHAIR
Vice director of the general surgery department, Chinese PLA General Hospital
Central Contacts
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References
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Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4.
Parisi A, Desiderio J. Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic, and open surgery for gastric cancer. Surgery. 2015 Apr;157(4):830-1. doi: 10.1016/j.surg.2014.12.007. Epub 2015 Jan 26. No abstract available.
Lee J, Kim YM, Woo Y, Obama K, Noh SH, Hyung WJ. Robotic distal subtotal gastrectomy with D2 lymphadenectomy for gastric cancer patients with high body mass index: comparison with conventional laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy. Surg Endosc. 2015 Nov;29(11):3251-60. doi: 10.1007/s00464-015-4069-1. Epub 2015 Jan 29.
Chuan L, Yan S, Pei-Wu Y. Meta-analysis of the short-term outcomes of robotic-assisted compared to laparoscopic gastrectomy. Minim Invasive Ther Allied Technol. 2015 Jun;24(3):127-34. doi: 10.3109/13645706.2014.985685. Epub 2014 Dec 3.
Suda K, Ishida Y, Uyama I. [Current status of robotic surgery for gastric cancer]. Gan To Kagaku Ryoho. 2014 Nov;41(11):1358-61. Japanese.
Huang KH, Lan YT, Fang WL, Chen JH, Lo SS, Li AF, Chiou SH, Wu CW, Shyr YM. Comparison of the operative outcomes and learning curves between laparoscopic and robotic gastrectomy for gastric cancer. PLoS One. 2014 Oct 31;9(10):e111499. doi: 10.1371/journal.pone.0111499. eCollection 2014.
Zong L, Seto Y, Aikou S, Takahashi T. Efficacy evaluation of subtotal and total gastrectomies in robotic surgery for gastric cancer compared with that in open and laparoscopic resections: a meta-analysis. PLoS One. 2014 Jul 28;9(7):e103312. doi: 10.1371/journal.pone.0103312. eCollection 2014.
Roviello F, Piagnerelli R, Ferrara F, Caputo E, Scheiterle M, Marrelli D. Assessing the feasibility of full robotic interaortocaval nodal dissection for locally advanced gastric cancer. Int J Med Robot. 2015 Jun;11(2):218-22. doi: 10.1002/rcs.1588. Epub 2014 Apr 15.
Son T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3.
Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.
Hyun MH, Lee CH, Kim HJ, Tong Y, Park SS. Systematic review and meta-analysis of robotic surgery compared with conventional laparoscopic and open resections for gastric carcinoma. Br J Surg. 2013 Nov;100(12):1566-78. doi: 10.1002/bjs.9242.
Marano A, Choi YY, Hyung WJ, Kim YM, Kim J, Noh SH. Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis. J Gastric Cancer. 2013 Sep;13(3):136-48. doi: 10.5230/jgc.2013.13.3.136. Epub 2013 Sep 30.
Liao GX, Xie GZ, Li R, Zhao ZH, Sun QQ, Du SS, Ren C, Li GX, Deng HJ, Yuan YW. Meta-analysis of outcomes compared between robotic and laparoscopic gastrectomy for gastric cancer. Asian Pac J Cancer Prev. 2013;14(8):4871-5. doi: 10.7314/apjcp.2013.14.8.4871.
Kim HI, Park MS, Song KJ, Woo Y, Hyung WJ. Rapid and safe learning of robotic gastrectomy for gastric cancer: multidimensional analysis in a comparison with laparoscopic gastrectomy. Eur J Surg Oncol. 2014 Oct;40(10):1346-54. doi: 10.1016/j.ejso.2013.09.011. Epub 2013 Sep 17.
Hyun MH, Lee CH, Kwon YJ, Cho SI, Jang YJ, Kim DH, Kim JH, Park SH, Mok YJ, Park SS. Robot versus laparoscopic gastrectomy for cancer by an experienced surgeon: comparisons of surgery, complications, and surgical stress. Ann Surg Oncol. 2013 Apr;20(4):1258-65. doi: 10.1245/s10434-012-2679-6. Epub 2012 Oct 19.
Ortiz-Oshiro E, Exposito PB, Sierra JM, Gonzalez JD, Barbosa DS, Fernandez-Represa JA. Laparoscopic and robotic distal gastrectomy for gastrointestinal stromal tumour: case report. Int J Med Robot. 2012 Dec;8(4):491-5. doi: 10.1002/rcs.1456. Epub 2012 Aug 29.
Other Identifiers
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sample20152018
Identifier Type: -
Identifier Source: org_study_id
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