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



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:May 2011
End Date:May 2020

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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

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.


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
We found this trial at
4
sites
Basking Ridge, New Jersey
Phone: 212-639-6244
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Basking Ridge, NJ
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-6244
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Middletown, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Ian Ganly, MD
Phone: 212-639-6244
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Rockville Centre, New York 11570
Phone: 212-639-6244
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Rockville Centre, NY
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