A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

Head and Neck Neoplasms Clinical Trial

Official title:

A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00627562
• Other study ID #: 07-03-080
• Status: Active, not recruiting
• Phase: N/A
• First received: February 5, 2008
• Last updated: March 15, 2016
• Start date: July 2007
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.

2. They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).

3. The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate.

4. Secondary objective include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.

5. To evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.

5. Endpoints will be compared to historical controls.

Description:

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device).22 Use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: December 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years f age

• Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck

• Written informed consent

Exclusion Criteria:

• Unexplained fever and/or untreated, active infection

• Pregnancy

• Previous head and neck surgery precluding transoral/endoscopic/robotic procedures

• Presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Device:
• robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gourin CG, Terris DJ. Surgical robotics in otolaryngology: expanding the technology envelope. Curr Opin Otolaryngol Head Neck Surg. 2004 Jun;12(3):204-8. Review. — View Citation

Hockstein NG, Nolan JP, O'Malley BW Jr, Woo YJ. Robot-assisted pharyngeal and laryngeal microsurgery: results of robotic cadaver dissections. Laryngoscope. 2005 Jun;115(6):1003-8. — View Citation

Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. — View Citation

Lobe TE, Wright SK, Irish MS. Novel uses of surgical robotics in head and neck surgery. J Laparoendosc Adv Surg Tech A. 2005 Dec;15(6):647-52. — View Citation

Tanna N, Joshi AS, Glade RS, Zalkind D, Sadeghi N. Da Vinci robot-assisted endocrine surgery: novel applications in otolaryngology. Otolaryngol Head Neck Surg. 2006 Oct;135(4):633-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ability to adequately visualize the operative field and complete planned surgery		1 day	No
Secondary	complication rate compared to standard endoscopic and minimally invasive procedures		1 month	Yes
Secondary	blood loss compared to historical controls of endoscopic and minimally invasive procedures		1 day	Yes
Secondary	quality of life at early (1-3 months) and late (one year)		1 year	No
Secondary	number of days hospitalized immediately after surgery		at discharge from hospital	No
Secondary	Time to recurrence of tumor or other pathology for which procedure was performed		at recurrence of tumor or pathology	No
Secondary	Time from start of treatment to death		at time of death	No