A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: Flexible Fiber-based CO2 Laser, Quality of Life forms; Other: electrocautery resection and quality of life forms

Study type: Interventional

Funder types: Other

Identifiers

NCT01355926

11-034

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Flexible Fiber-based CO2 Laser

Experimental group

Description:

In the CO2 excised group, the resection will be performed at 15W, at a distance of 1cm from the tissue. Here too, if required, the bipolar will be used to achieve hemostasis The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Treatment:

Other: Flexible Fiber-based CO2 Laser, Quality of Life forms

electrocautery resection

Experimental group

Description:

In the electrocautery excised group, the cut and coagulation modes used will be each at 25 Malis power setting. First, cut mode will be used to mark out the lesion. Subsequently, coagulation mode will be used for excision. Bipolar cautery will then be used at 25 Malis for hemostasis. The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Treatment:

Other: electrocautery resection and quality of life forms