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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with previous Head and Neck radiation
- •Pregnant or lactating female patients.
- •Patients with oral cavity squamous cell cancer requiring neck dissection
研究组 & 干预措施
Flexible Fiber-based CO2 Laser
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.
干预措施: Flexible Fiber-based CO2 Laser, Quality of Life forms (Other)
electrocautery resection
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.
干预措施: electrocautery resection and quality of life forms (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- to evaluate differences between the two surgical modalities(1 month)