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

This study is currently recruiting participants.
Verified July 2011 by Montefiore Medical Center
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00627562
First received: February 5, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose
  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.


Condition Intervention
Head and Neck Neoplasms
Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • ability to adequately visualize the operative field and complete planned surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication rate compared to standard endoscopic and minimally invasive procedures [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • blood loss compared to historical controls of endoscopic and minimally invasive procedures [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • quality of life at early (1-3 months) and late (one year) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of days hospitalized immediately after surgery [ Time Frame: at discharge from hospital ] [ Designated as safety issue: No ]
  • Time to recurrence of tumor or other pathology for which procedure was performed [ Time Frame: at recurrence of tumor or pathology ] [ Designated as safety issue: No ]
  • Time from start of treatment to death [ Time Frame: at time of death ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2007
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
robot assisted endoscopic head and neck surgery
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627562

Contacts
Contact: Catherine Sarta, BSN, RN 718-920-7054 csarta@montefiore.org
Contact: Richard V Smith, MD 718-920-8488 rsmith@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Richard V Smith, MD         
Sub-Investigator: Bradley A Schiff, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Study Chair: Richard V Smith, MD Montefiore Medical Center