Overview

This trial is active, not recruiting.

Condition head and neck neoplasms
Treatment robot assisted endoscopic head and neck surgery using the davinci robotic surgical system
Sponsor Montefiore Medical Center
Start date July 2007
End date June 2014
Trial size 71 participants
Trial identifier NCT00627562, 07-03-080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
robot assisted endoscopic head and neck surgery
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

Primary Outcomes

Measure
ability to adequately visualize the operative field and complete planned surgery
time frame: 1 day

Secondary Outcomes

Measure
complication rate compared to standard endoscopic and minimally invasive procedures
time frame: 1 month
blood loss compared to historical controls of endoscopic and minimally invasive procedures
time frame: 1 day
quality of life at early (1-3 months) and late (one year)
time frame: 1 year
number of days hospitalized immediately after surgery
time frame: at discharge from hospital
Time to recurrence of tumor or other pathology for which procedure was performed
time frame: at recurrence of tumor or pathology
Time from start of treatment to death
time frame: at time of death

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Montefiore Medical Center.