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

NCT00627562 | Unknown DMC

• 1 other identifier: 07-03-080
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques.
2. 2.They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.).
3. 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. 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. 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.

Conditions

Head and Neck Neoplasms

Keywords

robotic; robot assisted; minimally invasive; tumors of head and neck

Outcome Measures

Primary Outcomes (1)

• ability to adequately visualize the operative field and complete planned surgery

  1 day

Secondary Outcomes (6)

• complication rate compared to standard endoscopic and minimally invasive procedures

  1 month

• blood loss compared to historical controls of endoscopic and minimally invasive procedures

  1 day

• quality of life at early (1-3 months) and late (one year)

  1 year

• number of days hospitalized immediately after surgery

  at discharge from hospital

• Time to recurrence of tumor or other pathology for which procedure was performed

  at recurrence of tumor or pathology

Study Arms (1)

1

EXPERIMENTAL

robot assisted endoscopic head and neck surgery

Device: robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System

Interventions

robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System DEVICE

Planned endoscopic surgery of the head and neck performed with the DaVinci Robotic Surgical System

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related 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. doi: 10.1097/01.moo.0000122309.13359.af.

  PMID: 15167030 BACKGROUND

• 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. doi: 10.1212/01.WNL.0000164714.90354.7D.

  PMID: 15933510 BACKGROUND

• Hockstein NG, O'Malley BW Jr, Weinstein GS. Assessment of intraoperative safety in transoral robotic surgery. Laryngoscope. 2006 Feb;116(2):165-8. doi: 10.1097/01.mlg.0000199899.00479.75.

  PMID: 16467698 BACKGROUND

• 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. doi: 10.1089/lap.2005.15.647.

  PMID: 16366877 BACKGROUND

• 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. doi: 10.1016/j.otohns.2006.07.003. No abstract available.

  PMID: 17011430 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Richard V Smith, MD

  Montefiore Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman, Otorhinolaryngology/head and neck surgery

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: March 3, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2017
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)