Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer
NCT ID: NCT05035446
Last Updated: 2021-10-11
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
PHASE3
120 participants
INTERVENTIONAL
2021-10-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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single-incision plus one-port laparoscopic surgery(SILS + 1)
It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy
single-incision plus one-port laparoscopic surgery
The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.
conventional laparoscopic surgery(CLS)
It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy
conventional laparoscopic surgery
It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.
Interventions
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single-incision plus one-port laparoscopic surgery
The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.
conventional laparoscopic surgery
It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* clinically diagnosed cT1b-3N0-2M0 lesions according to the 8th Edition of the American Joint Committee on Cancer(AJCC) Cancer Staging Manual(measured using abdominal CT)
* tumor size ≤ 5cm
* planned to conduct subtotal gastrectomy
Exclusion Criteria
* tumor perforation
* severe mental disease
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Countries
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Facility Contacts
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References
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Kunisaki C, Miyamoto H, Sato S, Tanaka Y, Sato K, Izumisawa Y, Yukawa N, Kosaka T, Akiyama H, Saigusa Y, Sakamaki K, Yamanaka T, Endo I. Surgical Outcomes of Reduced-Port Laparoscopic Gastrectomy Versus Conventional Laparoscopic Gastrectomy for Gastric Cancer: A Propensity-Matched Retrospective Cohort Study. Ann Surg Oncol. 2018 Nov;25(12):3604-3612. doi: 10.1245/s10434-018-6733-x. Epub 2018 Sep 3.
Kashiwagi H, Kumagai K, Monma E, Nozue M. Dual-port distal gastrectomy for the early gastric cancer. Surg Endosc. 2015 Jun;29(6):1321-6. doi: 10.1007/s00464-014-3827-9. Epub 2014 Aug 27.
Zhou W, Dong CZ, Zang YF, Xue Y, Zhou XG, Wang Y, Ding YL. Initial experience of single-incision plus one port left-side approach totally laparoscopic distal gastrectomy with uncut Roux-en-Y reconstruction. World J Gastroenterol. 2020 Aug 21;26(31):4669-4679. doi: 10.3748/wjg.v26.i31.4669.
Kunisaki C, Makino H, Kimura J, Takagawa R, Ota M, Kosaka T, Akiyama H, Endo I. Application of reduced-port laparoscopic total gastrectomy in gastric cancer preserving the pancreas and spleen. Gastric Cancer. 2015 Oct;18(4):868-75. doi: 10.1007/s10120-014-0441-4. Epub 2014 Nov 15.
Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of Reduced Port Totally Laparoscopic Distal Gastrectomy (Duet TLDG) and Conventional Laparoscopic-Assisted Distal Gastrectomy. Ann Surg Oncol. 2015 Aug;22(8):2567-72. doi: 10.1245/s10434-014-4333-y. Epub 2015 Jan 7.
Yang X, Bu Z, He M, Lin Y, Jiang Y, Chen D, Liu K, Zhou J. Effectiveness and safety of reduced-port laparoscopic surgery vs conventional multi-port laparoscopic surgery in the treatment of gastric diseases: A meta-analysis. Medicine (Baltimore). 2021 Jan 22;100(3):e23941. doi: 10.1097/MD.0000000000023941.
Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of single-port and reduced-port totally laparoscopic distal gastrectomy for patients with early gastric cancer. Surg Endosc. 2016 Sep;30(9):3950-7. doi: 10.1007/s00464-015-4706-8. Epub 2015 Dec 22.
Kim HG, Kim DY, Jeong O. Transition from Conventional to Reduced-Port Laparoscopic Gastrectomy to Treat Gastric Carcinoma: a Single Surgeon's Experience from a Small-Volume Center. J Gastric Cancer. 2018 Jun;18(2):172-181. doi: 10.5230/jgc.2018.18.e18. Epub 2018 Jun 27.
Lu YM, Lin T, Hu YF, Liu H, Mou TY, Zhu Y, Yu J, Li GX. Initial Experience of Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer: A Single-Arm Study. Adv Ther. 2019 Sep;36(9):2342-2350. doi: 10.1007/s12325-019-01029-x. Epub 2019 Jul 23.
Other Identifiers
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SILS+1-GC-001
Identifier Type: -
Identifier Source: org_study_id
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