A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2007 |
| End Date: | December 2017 |
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.
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.
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.
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.
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
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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