Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00473564
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arm: 1
• Duration (Months): 106
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Oropharyngeal Cancer; Hypopharyngeal Cancer; Upper Aerodigestive Tract Neoplasms	Procedure: da Vinci® Robotic System	N/A

Detailed Description

This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TORS Candidates Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System	Procedure: da Vinci® Robotic System; Head and Neck Surgery using the da Vinci® Robotic System

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions [Intraoperatively average of 2 hours]

   Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Secondary Outcome Measures

1. Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery. [3 - 24 months postoperatively]

   Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;

• Lesion amendable to robotic assisted surgery treatment;

• Age > 19 years;

• Patient must sign informed consent.

Exclusion Criteria:

• Psychological condition that renders the patient unable to understand the informed consent;

• Poor mouth opening, with maximal opening less than 1.5 cm.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Medical Center	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: William Carroll, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00473564
• Other Study ID Numbers: F061228004; HNO 0601
• First Posted: May 15, 2007
• Last Update Posted: Mar 8, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham: Lesions; Biopsy; Surgery
• Additional relevant MeSH terms: Head and Neck Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms

Study Results

Participant Flow

Arm/Group Title	TORS Candidates
Arm/Group Description	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Period Title: Overall Study
STARTED	170
COMPLETED	147
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	TORS Candidates
Arm/Group Description	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Overall Participants	170
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	113 66.5%
>=65 years	57 33.5%
Sex: Female, Male (Count of Participants)
Female	43 25.3%
Male	127 74.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 0.6%
Black or African American	15 8.8%
White	154 90.6%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Description	Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Time Frame	Intraoperatively average of 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TORS Candidates
Arm/Group Description	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Measure Participants	170
Number of participants with adequate exposure	147 86.5%
Number of participants without adequate exposure	23 13.5%

2. Secondary Outcome

Title	Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Description	Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins
Time Frame	3 - 24 months postoperatively

Outcome Measure Data

Analysis Population Description

Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System

Arm/Group Title	TORS Candidates
Arm/Group Description	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Measure Participants	147
Known complication: oral hemorrhage	17 10%
Known complication: injury to perioral structures	1 0.6%
Known complication: airway edema	14 8.2%
Known complication: nerve injury	1 0.6%
Need for conversion to open procedure during surge	1 0.6%
Need for re-exicision due to positive margins	11 6.5%

Adverse Events

Time Frame	30 days
Arm/Group Title	TORS Candidates
Arm/Group Description	Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
All Cause Mortality
	TORS Candidates
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TORS Candidates
	Affected / at Risk (%)	# Events
Total	21/170 (12.4%)
Blood and lymphatic system disorders
leukocytosis	1/170 (0.6%)
Cardiac disorders
myocardial infarction	1/170 (0.6%)
Gastrointestinal disorders
oral cavity hemorrhage	6/170 (3.5%)
dysphagia	2/170 (1.2%)
vomiting	1/170 (0.6%)
General disorders
neck edema	1/170 (0.6%)
Metabolism and nutrition disorders
dehydration	5/170 (2.9%)
Musculoskeletal and connective tissue disorders
hip fracture	1/170 (0.6%)
Respiratory, thoracic and mediastinal disorders
aspiration pneumonia	2/170 (1.2%)
diffuse pharyngeal swelling	1/170 (0.6%)
excessive mucus in throat	1/170 (0.6%)
ARDS with respiratory failure	1/170 (0.6%)
pneumonia with respiratory distress	1/170 (0.6%)
respiratory distress	2/170 (1.2%)
chylothorax	1/170 (0.6%)
Other (Not Including Serious) Adverse Events
	TORS Candidates
	Affected / at Risk (%)	# Events
Total	121/170 (71.2%)
Gastrointestinal disorders
dysphagia	53/170 (31.2%)
oral pain	25/170 (14.7%)
Infections and infestations
oral yeast infection	10/170 (5.9%)
Musculoskeletal and connective tissue disorders
trismus	9/170 (5.3%)
Respiratory, thoracic and mediastinal disorders
hoarseness	15/170 (8.8%)
laryngeal edema	9/170 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.