Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

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ClinicalTrials.gov Identifier: NCT00473564

Recruitment Status : Completed

First Posted : May 15, 2007

Results First Posted : April 30, 2015

Last Update Posted : March 8, 2016

Sponsor:

Information provided by (Responsible Party):

William Carroll, MD, University of Alabama at Birmingham

Study Description

Brief Summary:

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer Oropharyngeal Cancer Hypopharyngeal Cancer Upper Aerodigestive Tract Neoplasms	Procedure: da Vinci® Robotic System	Not Applicable

Detailed Description:

This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	170 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Study Start Date :	February 2007
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Hypopharyngeal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: TORS Candidates Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System	Procedure: da Vinci® Robotic System Head and Neck Surgery using the da Vinci® Robotic System

Outcome Measures

Primary Outcome Measures :

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions [ Time Frame: Intraoperatively average of 2 hours ]
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Secondary Outcome Measures :

Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery. [ Time Frame: 3 - 24 months postoperatively ]
Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;
Lesion amendable to robotic assisted surgery treatment;
Age > 19 years;
Patient must sign informed consent.

Exclusion Criteria:

Psychological condition that renders the patient unable to understand the informed consent;
Poor mouth opening, with maximal opening less than 1.5 cm.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473564

Locations

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United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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Principal Investigator:	William Carroll, MD	University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4. doi: 10.1001/archoto.2010.40.

Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71. doi: 10.1016/j.otohns.2009.05.014.

Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. doi: 10.1001/archoto.2009.24.

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Responsible Party:	William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00473564
Other Study ID Numbers:	F061228004 HNO 0601 ( Other Identifier: UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee )
First Posted:	May 15, 2007 Key Record Dates
Results First Posted:	April 30, 2015
Last Update Posted:	March 8, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by William Carroll, MD, University of Alabama at Birmingham:


Lesions Biopsy Surgery

Additional relevant MeSH terms:

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Head and Neck Neoplasms Oropharyngeal Neoplasms Hypopharyngeal Neoplasms Neoplasms by Site Neoplasms	Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases

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