Clinical trial NCT01355926: A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery
Official title: Flexible Fiber-based CO2 Laser Versus Monopolar Cautery for Resection of Benign, Pre-malignant And Malignant Oral Cavity Lesions: A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Flexible Fiber-based CO2 Laser
Monopolar Cautery
Oral Cavity Lesions
Quality of life
Assessing Pain
11-034
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: OMNIGUIDE
First posted: 2011-05-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to help us to better understand the effects of two different types of surgical techniques on pain and quality of life in patients with precancerous lesions or early stage mouth cancers.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion. Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia)Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis of small superficial oral cavity SCC (stage T1N0) requiring resection without the need for neck dissection.
* All pathology will be reviewed at MSK to confirm diagnosis.
* The lesion plus the resection margin should not exceed 4.0 cm circumferentially.
* Planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection.
* All patients age 18 years of age and older.
* Karnofsky performance score over 60.

Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery. In the case of Coumadin, patients are switched to lovenox 7 days prior to surgery and this is stopped the day before surgery. Following surgery aspirin or Coumadin are recommenced 48 hours postop.

Exclusion Criteria:

* Patients with previous Head and Neck radiation
* Pregnant or lactating female patients.
* Patients with oral cavity squamous cell cancer requiring neck dissection

Primary outcomes:
measure: To demonstrate that for treatment of oral benign, oral leukoplakia and superficial T1N0M0 oral cavity lesions, CO2-fiber based resection generates less thermal damage compared to monopolar cautery
timeFrame: 1 month
Secondary outcomes:
measure: to evaluate differences between the two surgical modalities
timeFrame: 1 month
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ian Ganly, MD
role: PRINCIPAL_INVESTIGATOR
References: