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Clinical Trials/NCT01355926
NCT01355926CompletedNot Applicable

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

Memorial Sloan Kettering Cancer Center6 sites in 1 country68 target enrollmentStarted: May 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
6
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Outcomes

Primary Outcomes

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

Time Frame: 1 month

Leading to improved patient quality of life and post-operative recovery as manifested by reduced post-operative pain. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale.

Secondary Outcomes

  • to evaluate differences between the two surgical modalities(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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