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临床试验/CTRI/2024/04/066509
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

发起方
Dr Lanu Anuta Aimol
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Lanu Anuta Aimol

AIIMS Jodhpur

研究点 (1)

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