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临床试验/CTRI/2023/11/060063
CTRI/2023/11/060063招募中3 期

Comparing the outcomes of stapling with manual suturing for pharyngeal closure in laryngectomy

Institution Internal - Fluid Research Grant1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月12日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
1. Length of hospital stay

研究概览

简要总结

Laryngeal malignancies comprise upto 20% of head and neck cancers in india. sixty to eighty percentage of these are glottic malignancies.Total laryngectomy first performed by Theodor Billroth in 1873,is still the mainstay surgical treatment for advanced stage of laryngeal cancer, amenable to complete resection.It also forms an important salvage surgery option for patient who have failed organ preserving options like chemoradiation, radiotherapy alone or endolaryngeal laser surgery.Since the larynx shares common wall with posteriorly placed pharynx; post laryngectomy, the remaining larynx need to be closed anteriorly to make it a complete tube again. Pharyngocutaneous fistula is the one of the most common complication following  total laryngectomy, with reported rate varying between 3 to 65%.Various patient factors, disease factors and technique related factors found to have influence the formation of pharyngocutaneous fistula.The most commonly occured day 3 to day 8 post surgery and its presence is associated with higher morbidity, longer hospital stay, increased costs.The presence of a pharyngocutaneous fistula significantly delays the initiation of post operative radiotherapy, which leads to worse outcomes.Amongst the modifiable surgical technique related factors, a meticulous closure technique to close the pharyngeal defect after having adequately clear margin is paramount in preventing pharyngocutaneous fistula.There are two main methods for neopharynx closure,While conventional manual suturing of the mucosal and the muscle layers is the one commonly done,the other, more recently introduced-linear stapler pharyngoplsty is a novel technique which was first used post laryngectomy in 1971.Over the last few decades , it has gained popularity.Various studies have shown to reduce surgery time to approximately 80 minutes and lowers the fistula rate (22.9% vs 8.7%).The main aim of the presented study was to prospectively evaluate  and compare the outcomes of patients undergoing pharyngeal closure with the linear stapler or conventional suture technique after total laryngectomy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 89.00 Year(s)(—)
性别
All

入选标准

  • •any subject (irrespective of sex, age> 18 years) with endo laryngeal cancer (primary/salvage laryngectomy).

排除标准

  • •Patients with tumour extending to hypopharynx.

结局指标

主要结局

1. Length of hospital stay

时间窗: 1. In days | 2. Till 3 months post surgery(percentage/number)

2. Rate of pharyngocutaneous fistula

时间窗: 1. In days | 2. Till 3 months post surgery(percentage/number)

次要结局

  • 1.Pharyngeal closure time(2.Total surgery duration)

研究者

发起方
Institution Internal - Fluid Research Grant
申办方类型
Private medical college

研究点 (1)

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