Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx

Phase 1

Completed

• Conditions: Perioperative/Postoperative Complications; Head and Neck Cancer; Precancerous Condition
• Interventions: Procedure: assessment of therapy complications; Procedure: diagnostic endoscopic surgery; Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery; Procedure: therapeutic endoscopic surgery; Procedure: transoral robotic surgery; Procedure: video-assisted surgery

• Registration Number: NCT00918762
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.

PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.

Secondary

* Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.

OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.

Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.

Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.

After completion of study procedure, patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Primary Completion: 2010-02
• Study Completion: 2010-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
daVinci® Robotic Surgical System	therapeutic conventional surgery	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	therapeutic endoscopic surgery	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	assessment of therapy complications	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	quality-of-life assessment	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	diagnostic endoscopic surgery	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	transoral robotic surgery	Participants will undergo a planned surgical procedures via the robotic approach.
daVinci® Robotic Surgical System	video-assisted surgery	Participants will undergo a planned surgical procedures via the robotic approach.

Primary Outcome Measures

Name	Time	Method
Operative time that directly affects operative cost	post operative

Secondary Outcome Measures

Name	Time	Method
Need for reconstruction	post operative
Intra-operative and post-operative complications	during the operation and post operative
Margins status	post operative
Blood loss	During surgery
Length of hospital stay	during time as inpatient
Tracheostomy and PEG dependence	post operative
Days to oral intake	post operative
Speech intelligibility	post operative
Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion	post operative
Time to locoregional recurrence	post operative
Quality of life	3 months and 6 month following completion of surgery
Postoperative pain	post operative

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States