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临床试验/NCT07137507
NCT07137507已完成不适用

Comparison of Lung Expansion After Uniportal and Multiportal Video Assisted Thoracic Surgery for Stage II Post Pneumonic Bacterial Empyema Thoracis

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
complete lung expansion after decortication

研究概览

简要总结

It was a parallel-armed randomized control study in which 160 participants admitted to the Thoracic Surgery Department, Services Hospital, Lahore were included. The participants were divided into two equal groups (80 in each group). Uniportal Group participants underwent uniportal video assisted thoracic surgery (VATS), while multiportal Group participants were treated with multiportal video assisted thoracic surgery(VATS). Simple consecutive sampling was carried out. Expansion of lung was evaluated postoperatively at the 1st, 3rd, 7th and 15th postoperative day by chest radiograph after uniportal and multiportal VATS.

详细描述

Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion. Traditionally, the surgical approach was open thoracotomy; then the multiportal video assisted thoracic surgery (VATS) approach became more common. Recently, more surgeons are adopting the uniportal VATS approach, which has become a powerful surgical tool, for the treatment of stage II empyema.

Uniportal and multiportal VATS are a feasible technique in all patients with pleural empyema requiring surgery. In this study, the investigators observed comparable postoperative success rates, no need for conversion, and successful completion of decortication via both multiportal and uniportal approaches. This transition to a single-incision technique was associated with fewer chest tubes, minimal surgical trauma, and no compromise in clinical outcomes.

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 (Investigator)

盲法说明

Allocation concealment was maintained using sealed, opaque envelopes prepared by an independent staff member not involved in patient recruitment or data collection. Blinding was applied at the outcome assessment stage, with the radiologists evaluating postoperative lung expansion unaware of the surgical approach used.

入排标准

年龄范围
18 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stage II empyema
  • More than 18 years old patients deemed fit for intervention.
  • Both genders
  • Unintubated patients

排除标准

  • Patients with stages I and III empyema
  • Patient with TB empyema
  • Patient with Fungal empyema
  • Patients unfit for general anesthesia.
  • Unwilling to participate

结局指标

主要结局

complete lung expansion after decortication

时间窗: 15 days

Complete expansion of lung after Uniportal or Multiportal VATS was defined as, no residual pneumothorax or fluid collection on the chest radiograph, post - operatively. Lung expansion after surgery will be measured in percentages by calculating percentage of residual pneumothorax or fluid collection and was assessed using chest X-ray. Chest x-rays were performed on post-operative day 1, 3, 7 and 15. Physiologically normal and completely expanded lung is the set parameter for checking and comparing the expansion of operated lung after decortication.

次要结局

  • post-operative thoracotomy site pain(07 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeeshan Sarwar

Principal Investigator

University of Health Sciences Lahore

研究点 (1)

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