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临床试验/NCT06132997
NCT06132997尚未招募不适用

Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management

Hend Mohamed Sayed Mohamed0 个研究点目标入组 100 人开始时间: 2023年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Treatment success:

研究概览

简要总结

To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone.

To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods.

To asses resolution of pleural infection and rates of fluid re-accumulation over follow-up.

To compare safety profiles and complication rates of thoracoscopy versus tube drainage alone

详细描述

Empyema is a serious infection characterized by pus accumulation in the pleural space. Effective drainage and treatment is necessary for resolution. Traditionally, intercostal tube placement was standard initial management. However, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (VATS).

Thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. Also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management.

Additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. Overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.

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)

盲法说明

Intercostal chest tube group

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of empyema via Imaging tests (e.g. chest x-ray/CT scan)
  • Age 18 years or older
  • Clinical signs/symptoms consistent with Empyema such as fever, chest pain, coughs
  • Pleural fluid loculations/septations seen on Imaging requiring drainage
  • No previous drainage procedures done for Current empyema

排除标准

  • Age less than 18 years
  • Immunocompromised state or other conditions Contraindications to thoracoscopy
  • Previous drainage procedure for current Empyema
  • Residual pleural fluid not amenable to drain

结局指标

主要结局

Treatment success:

时间窗: baseline

Asses by chest ultrasound

次要结局

  • Success of pleurodesis(baseline)

研究者

发起方
Hend Mohamed Sayed Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hend Mohamed Sayed Mohamed

Principal investigator

Assiut University

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