CTRI/2024/04/066509尚未招募Phase 3 4
Comparison of surgical outcomes of cold dissection, coblation and CO2 laser in patients undergoing tonsillectomy.
Dr Lanu Anuta Aimol1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-Operative Pain
研究概览
简要总结
Aims and Objectives: To study and compare the surgical outcomes of Cold Dissection, Coblation and CO2 Laser in patients undergoing tonsillectomy.
Objectives:
1.To assess the outcomes of tonsillectomy by cold dissection, CO2 laser and coblation method.
2.To compare the surgical outcomes for pain, bleeding and complications.
Detailed methodology:
- A Randomised Controlled Trial is planned for comparing surgical outcomes of cold dissection, coblation and CO2 laser in patients undergoing tonsillectomy in the Department of Otorhinolaryngology, AIIMS, Jodhpur.
- Patients will be subjected to surgery as per Pre-op protocol and discussion.
- Randomisation will be done using envelopes which contain the name of the arm under which the patient will be included (single blinded).
- Patients undergoing tonsillectomy will be divided into three random groups and different techniques (Cold Dissection, Coblation, CO2 Laser ) will be used.
- Intra operative bleeding will be noted based on anaesthesiologist’s documentation which includes soakage of gauge pieces and blood collected in suction apparatus as per our form.
- The surgical outcomes of these techniques will be evaluated postoperatively for pain, bleeding and complications till 3 months.
- Post operative pain will be assessed on day 1, 3, 7 and 14 with the help of VAS (Visual Analogue Scale, Faces Rating Scale)
- The patient will be assessed post operatively for status of tonsillar fossa- healthy/unhealthy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Month(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Any patients undergoing tonsillectomy.
排除标准
- •Patients with bleeding diathesis, anaemia, Oropharyngeal Squamous Cell Carcinoma and patients not consenting for surgery.
结局指标
主要结局
Post-Operative Pain
时间窗: 2 years
次要结局
- 1. Intra-Operative and Post-Operative bleeding(2. Complications)
研究者
Dr Lanu Anuta Aimol
AIIMS Jodhpur
研究点 (1)
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