Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

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Detailed Description

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Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transoral Robotic Surgery (TORS)

Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System

Group Type EXPERIMENTAL

Da Vinci Robotic Transoral Robotic Surgical System

Intervention Type DEVICE

(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Interventions

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Da Vinci Robotic Transoral Robotic Surgical System

(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Intervention Type DEVICE

Other Intervention Names

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(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Eligibility Criteria

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Inclusion Criteria

* Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
* Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria

* Unexplained fever and/or untreated, active infection
* Patient pregnancy
* Previous head and neck surgery precluding transoral/robotic procedures
* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No