Brief 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.
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.
Brief Title
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Head and Neck Neoplasms
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
robotic
robot assisted
minimally invasive
tumors of head and neck
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00627562
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
07-03-080
Overall Status
Unknown status
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
Primary Outcomes
Outcome Measure
ability to adequately visualize the operative field and complete planned surgery
Outcome Time Frame
1 day
Secondary Outcomes
Outcome Time Frame
1 month
Outcome Measure
complication rate compared to standard endoscopic and minimally invasive procedures
Outcome Time Frame
1 day
Outcome Measure
blood loss compared to historical controls of endoscopic and minimally invasive procedures
Outcome Time Frame
1 year
Outcome Measure
quality of life at early (1-3 months) and late (one year)
Outcome Time Frame
at discharge from hospital
Outcome Measure
number of days hospitalized immediately after surgery
Outcome Time Frame
at recurrence of tumor or pathology
Outcome Measure
Time to recurrence of tumor or other pathology for which procedure was performed
Outcome Time Frame
at time of death
Outcome Measure
Time from start of treatment to death
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Richard Smith
Investigator Email
RSMITH@MONTEFIORE.ORG
Investigator Phone
718-920-4646