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Head & Neck Clinical Evidence

The following selected publications support the clinical efficacy of da Vinci® Head and Neck Surgery. For additional citations on robotic surgery, please visit PubMed (Medline).

Please note: PubMed provides links to downloadable PDFs which are usually available from the journal publisher for a fee. You may also contact academic libraries (for example, University of California) and inquire about their document delivery services.

Clinical References - The following selected publications support the clinical efficacy of da Vinci® Head and Neck Surgery. For additional citations on robotic surgery, please visit PubMed (Medline).

Please note: PubMed provides links to downloadable PDFs, which are usually available from the journal publisher for a fee. You may also contact academic libraries (for example, University of California) and inquire about their document delivery services

Throat cancer

"Transoral robotic surgery: supraglottic partial laryngectomy." Weinstein, G. S., B. W. O'Malley, Jr., et al. (2007). Ann Otol Rhinol Laryngol 116(1): 19-23.

OBJECTIVES: We assessed the feasibility of performing transoral supraglottic partial laryngectomy with robotic instrumentation.
METHODS: Transoral robotic surgery (TORS) was performed on 3 human patients with supraglottic carcinoma in a prospective human trial. The study was approved by our institutional review board and involved the da Vinci Surgical Robot (Intuitive Surgical, Inc, Sunnyvale, California).
RESULTS: All procedures were completed robotically. The median overall operation time to perform the robotic procedure was 120 minutes (range, 1:32:48 to 2:58:18), including 18 minutes (range, 00:6:07 to 00:30:39) for exposure and robotic positioning. There were no intraoperative or postoperative complications or surgical mortality.
CONCLUSIONS: The preliminary results of our series suggest that application of the da Vinci robotic surgical system for TORS to supraglottic partial laryngectomy is technically feasible and relatively safe. Furthermore, TORS provides excellent surgical exposure that allows complete tumor resection. Most importantly, TORS provides an alternative to open approaches and "conventional" transoral supraglottic partial laryngectomy.

"Transoral robotic surgery: radical tonsillectomy." Weinstein, G. S., B. W. O'Malley, Jr., et al. (2007). Arch Otolaryngol Head Neck Surg 133(12): 1220-1226.

OBJECTIVE: To describe and show the feasibility of a new surgical technique for transoral robotic surgery (TORS) radical tonsillectomy.
DESIGN: A prospective, phase 1 clinical trial.
SETTING: Academic, tertiary referral center.
PATIENTS: A total of 27 participants were prospectively selected using a volunteer sample. All eligible patients agreed to participate in the study.
INTERVENTIONS: Patients underwent TORS radical tonsillectomy for previously untreated invasive squamous cell carcinoma of the tonsillar region without free-flap reconstruction, staged neck dissection, and adjuvant therapy.
MAIN OUTCOME MEASURES: Outcome measures included final pathologic margin status, need for short- and long-term tracheotomy tube placement, and need for gastrostomy tube feedings among patients with a minimum 6-month follow-up. The incidence of significant postoperative complications was recorded.
RESULTS: No mortality occurred. Final margins found to be negative for cancer were achieved in 25 of 27 patients (93%). Surgical complications included 1 case each of postoperative mucosal bleeding, delirium tremens, unplanned tracheotomy for temporary exacerbation of sleep apnea, and hypernasality and 2 cases of moderate trismus. Twenty-six of 27 patients (96%) were swallowing without the use of a gastrostomy.
CONCLUSIONS: Radical tonsillectomy using TORS is a new technique that offers excellent access for resection of carcinomas of the tonsil with acceptable acute morbidity. Future reports will focus on long-term oncologic and functional outcomes.

"Robot-assisted surgery for upper aerodigestive tract neoplasms." Boudreaux, B. A., E. L. Rosenthal, et al. (2009). Archives of otolaryngology--head & neck surgery 135(4): 397-401.

OBJECTIVES: To assess the feasibility and safety of performing robot-assisted resections of head and neck tumors, and to predict which variables lead to successful robot-assisted resection and better functional outcome.
DESIGN: Prospective nonrandomized clinical trial.
SETTING: Academic tertiary referral center.
PATIENTS: Thirty-six patients with oral cavity, oropharyngeal, hypopharyngeal, or laryngeal tumors.
INTERVENTION: Robot-assisted resection of indicated tumors.
MAIN OUTCOME MEASURES: Ability to perform robot-assisted resection, final pathologic margin status, ability to extubate postoperatively, need for tracheotomy tube, and need for gastrostomy tube. Any clinically significant complications were recorded.
RESULTS: Thirty-six patients participated in the study. Eight patients had previously been treated for head and neck cancer. Twenty-nine patients (81%) underwent successful robotic resection. Negative margins were obtained in all 29 patients. Twenty-one of 29 patients were safely extubated prior to leaving the operating room. One patient required short-term tracheotomy tube placement. A total of 9 patients were gastrostomy tube dependent (2 preoperatively, 7 postoperatively). Factors associated with successful robotic resection were lower T classification (P = .01) and edentulism (P = .07). Factors associated with gastrostomy tube dependence were advanced age (P = .02), tumor location in the larynx (P < .001), higher T classification (P = .02), and lower preoperative M. D. Anderson Dysphagia Inventory score (P = .04).
CONCLUSIONS: Robot-assisted surgery is feasible and safe for the resection of select head and neck tumors. This clinical series demonstrates that robotic surgery can be utilized successfully in patients with T1 to T4 lesions located in the oral cavity, oropharynx, hypopharynx, and larynx with good preservation of swallow function.

"Transoral robotic surgery for the management of head and neck cancer: a preliminary experience." Genden, E. M., S. Desai, et al. (2009). Head Neck 31(3): 283-289.

BACKGROUND: The aim of this prospective study was to determine the technical feasibility, safety, and efficacy of transoral robotic surgery (TORS) for a variety of malignant head and neck lesions.
METHODS: From April 2007 to November 2007, 20 patients were enrolled in an institutional review board-approved prospective trial using the da Vinci surgical robot. Inclusion criteria for the study consisted of adults with early head and neck cancer involving the oral cavity, oropharynx, hypopharynx, and larynx.
RESULTS: Twenty patients were included in this study. In 2 cases, access to the tumor was inadequate and the procedure was terminated. In all 18 cases, negative resection margins were achieved. Intraoral reconstruction was performed in 8 patients. Fifteen of 18 patients underwent concomitant unilateral (n = 10) or bilateral (n = 5) selective neck dissections. None of the patients required tracheotomy and there were no intraoperative or postoperative complications. The average setup time was 54.6 minutes (range, 140-20 minutes), with a precipitous decrease in the setup time as the study progressed.
CONCLUSION: TORS is a safe, feasible, and minimally invasive alternative to classic open surgery or endoscopic transoral laser surgery in patients with early cancer of the head and neck. With increasing experience, surgical setup as well as operative time will continue to decrease.

"Functional outcomes after transoral robotic surgery for head and neck cancer." Iseli, T. A., B. D. Kulbersh, et al. (2009). Otolaryngology - Head and Neck Surgery 141(2): 166-171.

OBJECTIVE: To evaluate functional outcomes following transoral robotic surgery for head and neck cancer.
STUDY DESIGN: Case series with planned data collection. Setting: Academic hospital. Subjects and Methods: Between March 2007 and December 2008, 54 of 62 candidate patients underwent transoral robotic tumor resection. Outcomes include airway management, swallowing (MD Anderson Dysphagia Inventory), and enterogastric feeding.
RESULTS: Tumors were most commonly oropharynx (61%) or larynx (22%) and T1 (35%) or T2 (44%). Many received radiotherapy (22% preoperatively, 41% postoperatively) and chemotherapy (31%). Endotracheal intubation was retained (22%) for up to 48 hours, tracheostomy less frequently (9%), and all were decannulated by 14 days. Most commenced oral intake prior to discharge (69%) or within two weeks (83%). A worse postoperative Dysphagia Inventory score was associated with retained feeding tube (P = 0.020), age >60 (P = 0.017), higher T stage (P = 0.009), laryngeal site (P = 0.017), and complications (P = 0.035). At a mean 12 months' follow-up, 17 percent retained a feeding tube (9.5% among primary cases). Retained feeding tube was associated with preoperative tube requirement (P = 0.017), higher T stage (P = 0.043), oropharyngeal/laryngeal site (P = 0.034), and recurrent/second primary tumor (P = 0.008). Complications including airway edema (9%), aspiration (6%), bleeding (6%), and salivary fistula (2%) were managed without major sequelae.
CONCLUSION: Transoral robotic surgery provides an emerging alternative for selected primary and salvage head and neck tumors with low morbidity and acceptable functional outcomes. Patients with advanced T stage, laryngeal or oropharyngeal site, and preoperative enterogastric feeding may be at increased risk of enterogastric feeding and poor swallowing outcomes. ©2009 American
Academy of Otolaryngology-Head and Neck Surgery Foundation.

"A pilot study to evaluate the use of the da Vinci surgical Robotic system in Transoral surgery for lesions of the oral cavity and pharynx." Mardirossian, V. A., M. C. Zoccoli, et al. (2009). Laryngoscope 119(SUPPL. 1): 7.

EDUCATIONAL OBJECTIVE: At the conclusion of this presentation, the participants should be able to discuss the role of robotic surgery in the head and neck.
OBJECTIVES: The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) has been used in many fields with great success including: Urologic, General, Cardiothoracic, and Gynocological surgeries. The same benefits that this method offers to these specialties can be utilized in the realm of the head and neck. The aim study of this study is to evaluate the potential advantages of Transoral Robotic Surgery (TORS) specifically looking at precision, dexterity, visualization and exposure of the surgical site, surgical time, recovery of speech and swallowing function, degree of pain and discomfort and incidence of bleeding.
STUDY DESIGN: Prospective Clinical Trial.
METHODS: 10 patients with lesions of the oral cavity and pharynx were recruited for this study. The following timing parameters were recorded: 1. intraoperative set up time. 2. Time to obtain surgical bed exposure. 3. The duration of the surgery. 4. Days until swallowing recovery. 5. Days until speech recovery. Additionally, the following parameters were recorded: 1. Quality of surgical bed exposure. 2. Complications. 3. Pain intensity/duration. 4. Operative bleeding. 5. Postoperative Bleeding.
RESULTS: All ten surgeries were performed between June 2007 and October 2008. The intraoperative set up time was generally less than 45 min, the major part being less than 30 min. Minimal time (less than 4 min) was required in order to obtain an excellent surgical exposure in all cases. The duration of the surgery was less than 95 min with a maximum of blood loss of 100 mililiters. There were no intraoperative or postoperative complications and speech and swallowing recovery generally did not exceed 2 days. There was minimal postoperative pain and residual bleeding.
CONCLUSIONS: The da Vinci robotic system is a safe and reliable instrument for transoral removal of lesions in the oral cavity and pharynx. Our study supports this conclusion with minimal time to speech and swallowing recovery after surgery, along with reduced postoperative pain and absence of complications in our patients.

"Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes." Moore, E. J., K. D. Olsen, et al. (2009). Laryngoscope 119(11): 2156-2164.

OBJECTIVES/HYPOTHESIS: To investigate the feasibility of transoral robotic surgery as a method of surgical treatment of oropharyngeal squamous cell carcinoma.
STUDY DESIGN: Prospective case study.
METHODS: Forty-five patients with previously untreated oropharyngeal squamous cell carcinoma underwent transoral robotic surgical removal of the tumor with or without neck dissection and with or without adjuvant therapy. Patients were observed and data were recorded on surgical time, blood loss, surgical complications, tracheostomy tube course, enteral feeding, and resumption of oral diet, speech outcomes, swallowing outcomes, and tumor recurrence.
RESULTS: All 45 patients underwent complete transoral robotic surgical excision with simultaneous unilateral or bilateral neck dissection. Margins were negative for tumor. Mean operating time for tumor removal was 71.3 minutes for the last 35 cases. There were 15 stage T1 tumors, 18 T2 tumors, 3 T3 tumors, and 9 T4a tumors. Twenty-six patients had base of tongue primary tumors and 19 had tonsillar fossa tumors. Fourteen patients had a tracheostomy tube placed at surgery, and all patients had their tracheostomy tube removed (mean duration of use, 7.0 days). Twenty-two patients (48.9%) had a nasogastric feeding tube placed, and all patients had their feeding tube removed (mean duration of use, 12.5 days). Eight patients had percutaneous gastrostomy (PEG) tubes placed, and all eight eventually had their PEG tubes removed (mean duration of use, 140.3 days). Average hospital stay was 3.8 days. There were no major complications and no procedure was aborted because of an inability to remove the tumor.
CONCLUSIONS: Transoral robotic surgery is a safe and efficacious method of surgical treatment of oropharyngeal neoplasms. Advantages of the technique include adequate ability to visualize and manipulate with two hands lesions in the base of tongue. Patients were able to retain or rapidly regain oropharyngeal function in the majority of cases.

"Feasibility of transoral lateral oropharyngectomy using a robotic surgical system for tonsillar cancer." Park, Y. M., J. G. Lee, et al. (2009). Oral oncology.

Conventional surgical approaches for tonsillar carcinomas have a great risk for developing treatment-related morbidity. To minimize this morbidity, transoral lateral oropharyngectomy (TLO) using the robotic surgical system was performed, and the efficacy and feasibility of this procedure was evaluated. TLO was performed using the da Vinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA). It consists of a surgeon's console and a manipulator cart equipped with three robotic arms. The surgeon is provided with three- dimensional magnified images from the endoscopic arm and can control two instrument arms for delicate operations from the console. Safe resection of tonsillar carcinoma was possible with the three-dimensional magnified images. When proceeding with resection of the buccopharyngeal fascia, we could prevent damage to the carotid artery, which is located posterolateral to the tonsillar fossa, since the joint at the distal part of the robotic arm can be bent freely from side to side. By using the 30 degrees endoscope, we can achieve a better surgical view of the base of the tongue area. TLO was performed successfully in all five patients without surgical complications. The mean operating time was 44min, and an average of 19min was required for setting up the robotic system. TLO using the robotic system will be a good option for organ preservation therapy in the treatment of carcinomas of the tonsil and the tonsillar fossa in the future.

"Transoral robotic surgery: does the ends justify the means?" Weinstein, G. S., B. W. O'Malley, Jr., et al. (2009). Curr Opin Otolaryngol Head Neck Surg 17(2): 126-131.

PURPOSE OF REVIEW: Head and neck surgical science has developed dramatically during the past 20 years with a major focus on organ preservation surgery. Among these organ preserving surgeries are the selective neck dissections, supracricoid partial laryngectomies, transoral laser surgeries, and now a newcomer, transoral robotic surgery utilizing the da Vinci Surgical System. Transoral robotic surgery is in its infancy, but, indeed, there have been some questions raised about the role of these innovative robotic surgical techniques.
RECENT FINDINGS: This article will review, point by point, the questions that have been raised concerning the feasibility; safety and efficacy; teachability; and cost effectiveness of transoral robotic surgery.
SUMMARY: Although the present literature reports early findings, without long- term oncologic outcomes, the results are consistently encouraging. Training programs have already yielded successes. Indeed, multiple institutions have shown that transoral robotic surgery programs can be successfully established yielding excellent clinical outcomes. In addition, early studies of swallowing function following transoral robotic surgery show swallowing outcomes that are superior to some of the reported chemoradiation results for equivalent lesions.