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Article: Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery

TitleProspective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery
Authors
KeywordsRobotic surgery
Single port
Transoral robotic surgery
TORS
Clinical trialTransoral
Issue Date2019
PublisherPergamon. The Journal's web site is located at http://www.elsevier.com/locate/oraloncology
Citation
Oral Oncology, 2019, v. 94, p. 101-105 How to Cite?
AbstractIntroduction: The aim of this study was to determine the clinical safety and feasibility of a novel single-port flexible robot for Transoral Robotic Surgery (TORS). Materials and methods: This was a prospective phase II / IDEAL stage 2 clinical trial of both benign and malignant lesions of the head and neck. The primary endpoint included conversion rates and perioperative complications within 30 days following surgery. The study was registered on www.ClinicalTrials.gov (NCT03010813). The Fisher’s exact test and Mann-Whitney U test were used to compare categorical, and non-parametric data for the trial. A p value <0.05 was considered to be statistically significant. Statistical analysis was performed with SPSS 20.0 (IBM Corp., Armonk, New York) Results: Twenty-one patients safely underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA) demonstrating the feasibility of access to the nasopharynx, oropharynx, larynx and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all patients. Conclusions: In a prospective Phase II clinical trial, a novel single-port flexible robotic system appears safe and feasible to use for transoral endoscopic head and neck surgery to access the nasopharynx, oropharynx, larynx and hypopharynx.
Persistent Identifierhttp://hdl.handle.net/10722/272997
ISSN
2017 Impact Factor: 4.636
2015 SCImago Journal Rankings: 1.764

 

DC FieldValueLanguage
dc.contributor.authorChan, JYK-
dc.contributor.authorTsang, RKY-
dc.contributor.authorHolsinger, FC-
dc.contributor.authorTong, MCF-
dc.contributor.authorNg, CWK-
dc.contributor.authorChiu, PWY-
dc.contributor.authorNg, SSM-
dc.contributor.authorWong, EWY-
dc.date.accessioned2019-08-06T09:20:38Z-
dc.date.available2019-08-06T09:20:38Z-
dc.date.issued2019-
dc.identifier.citationOral Oncology, 2019, v. 94, p. 101-105-
dc.identifier.issn1368-8375-
dc.identifier.urihttp://hdl.handle.net/10722/272997-
dc.description.abstractIntroduction: The aim of this study was to determine the clinical safety and feasibility of a novel single-port flexible robot for Transoral Robotic Surgery (TORS). Materials and methods: This was a prospective phase II / IDEAL stage 2 clinical trial of both benign and malignant lesions of the head and neck. The primary endpoint included conversion rates and perioperative complications within 30 days following surgery. The study was registered on www.ClinicalTrials.gov (NCT03010813). The Fisher’s exact test and Mann-Whitney U test were used to compare categorical, and non-parametric data for the trial. A p value <0.05 was considered to be statistically significant. Statistical analysis was performed with SPSS 20.0 (IBM Corp., Armonk, New York) Results: Twenty-one patients safely underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA) demonstrating the feasibility of access to the nasopharynx, oropharynx, larynx and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all patients. Conclusions: In a prospective Phase II clinical trial, a novel single-port flexible robotic system appears safe and feasible to use for transoral endoscopic head and neck surgery to access the nasopharynx, oropharynx, larynx and hypopharynx.-
dc.languageeng-
dc.publisherPergamon. The Journal's web site is located at http://www.elsevier.com/locate/oraloncology-
dc.relation.ispartofOral Oncology-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectRobotic surgery-
dc.subjectSingle port-
dc.subjectTransoral robotic surgery-
dc.subjectTORS-
dc.subjectClinical trialTransoral-
dc.titleProspective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery-
dc.typeArticle-
dc.identifier.emailTsang, RKY: rkytsang@hku.hk-
dc.identifier.authorityTsang, RKY=rp01386-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1016/j.oraloncology.2019.05.018-
dc.identifier.pmid31178203-
dc.identifier.scopuseid_2-s2.0-85066295147-
dc.identifier.hkuros300934-
dc.identifier.volume94-
dc.identifier.spage101-
dc.identifier.epage105-
dc.publisher.placeUnited Kingdom-

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