NCT01355926已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 6
- 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
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)
研究者
研究点 (6)
Loading locations...
相似试验
尚未招募
4 期
CO2 Laser vs Traditional Scalpel for surgical management of oral precancerous lesionsCTRI/2024/02/063297Dr Vartik Shah
已完成
不适用
Comparison of CO2 and diode lasers in gingival pigmentatioIRCT20091118002736N4Mashhad University of Medical Sciences12
已完成
2 期
Comparison of the effect of co2 laser versus co2 laser and PRP on periorbital hyperpigmentatioperiorbital hyperpigmentation.Disorder of pigmentation, unspecifiedIRCT2015103118210N4vice chancellor of Iran University of Medical Sciences research committee100
招募中
不适用
Comparison of Conventional and Laser techniques in treatment of gingival pigmentation in adultsGingival pigmentation.IRCT20170601034288N1Semnan University of Medical Sciences15
尚未招募
不适用
A comparative study on efficacy of CO2 laser and topical 2% clotrimazole daily application versus Nd: YAG laser and topical 2% clotrimazole daily application with lasers given at interval of 3 weeks to maximum of 6 sessions in treatment of onycomycosisCTRI/2022/10/046393Chengalpattu medical college and hospital