Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03804385 |
| Other study ID # |
Pneumothoracic |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
January 30, 2021 |
Study information
| Verified date |
January 2019 |
| Source |
Assiut University |
| Contact |
Mohamed Abdel-kader Osman Ahmed, MHD |
| Phone |
+201062226639 |
| Email |
osman[@]med.aun.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the different surgical management in patients with primary pneumothorax 0 Objective 1:
Identify risk factors that are predictive of the need for surgical intervention.
- Objective 2: Determine the value of management strategies in terms of hospital stay
- Objective 3: Assess outcomes and postoperative results including symptom relive ,or
recurrence or post-operative complications .
Description:
pneumothorax is defined as air or gas accumulated in the pleural cavity. Spontaneous
pneumothorax can be classified as either primary or secondary. Primary spontaneous
pneumothorax , which is defined as a pneumothorax without underlying lung disease,
predominantly occurs in young, thin males. It is usually caused by ruptured pleural blebs or
bullae. Secondary spontaneous pneumothorax usually occurs in older people with underlying
pulmonary disease, such as emphysema or asthma, acute or chronic infections, lung cancer, and
congenital diseases including cystic fibrosis, catamenial pneumothorax , or
lymphangio-leiomyomatosis .
The age-adjusted incidence of Primary spontaneous pneumothorax is from 7.4 to 18 per 100 000
population per year in males, and from 1.2 to 6 per 100 000 population per year in females.
It usually occurs in tall, thin males of 10 to 30 years old. Less often does it occur in
people at the age of more than 40 years. Primary spontaneous pneumothorax might be associated
with some congenital disorders such as Marfan's syndrome, or some environmental factors such
as smoking. Primary spontaneous pneumothorax usually occurs at rest. Approximately 10% of
patients with Primary spontaneous pneumothorax have a positive family history. Smoking is
also regarded as a precipitating factor for Primary spontaneous pneumothorax. The relative
risk of pneumothorax ranged from 7 to 100 times higher in light to heavy smokers Most authors
believe that Primary spontaneous pneumothorax results from spontaneous rupture of a
sub-pleural bleb or bulla. However, only a portion of patients with Primary spontaneous
pneumothorax could be found with blebs or bullae in imaging or at the time of surgery. Other
mechanisms may be considered, such as increase in pleural porosity secondary to inflammation.
The development of bullae, blebs, or pleural porosity might be related to many factors, such
as distal airway inflammation, distal bronchial tree anomaly, disorders of connective tissue
formation, local ischemia, and malnutrition.
Primary spontaneous pneumothorax usually occurs at rest, and presents with acute onset of
local pleuritic chest pain accompanied by dyspnoea. This pain may be mild or severe, sharp
and steady ache in character, and usually resolves within 24 h even though pneumothorax still
exists. On physical examination, decreased air entry on auscultation, decreased chest wall
movement on inspection, hyper-resonance (tympanic) on percussion are most often detected in
patients with large pneumothorax (free air occupies more than 15% to 20% area of hemi
thorax). Reflex tachycardia can be found in most patients in response to discomfort or
circulating or respiratory compromise. Tension pneumothorax should be suspected if severe
tachycardia, cold sweating, hypotension, or cyanosis has developed. Blood gas analysis in
patients with large pneumothoraces may reveal increased alveolar-arterial difference in
oxygen partial pressure (PA-aO2) due to increased intrapulmonary shunt from the collapsed
lung.
Most Primary spontaneous pneumothorax cases are confirmed by upright posteroanterior chest
radiograph, which can be used to assess the pneumothorax size with good accuracy. A pleural
line with or without an air-fluid level can be seen in the chest radiograph, but sometimes it
is difficult to detect these signs, especially in patients with small pneumothoraces,
emphysema, or poor exposure of the film. Expiratory chest radiographs have no diagnostic
value for patients with Primary spontaneous pneumothorax.
Computed tomography (CT) of the chest can be used to detect patients with small penman-thorax
(less than 15% area of hemi thorax). In addition, CT can provide more detailed information to
assist in the subsequent management. Findings which can be noted include the number, size,
and location of bullae/blebs (ipsi- or contra-laterally), as well the possibilities of
pleural adhesion, pleural fluid accumulation, and possible underlying pulmonary diseases. For
more than 90% of patients with Primary spontaneous pneumothorax, pathological lung changes
can be detected by CT. The most common type is few (n<5) and small (<2 cm in diameter) blebs,
followed by mixed blebs and bullae (>2 cm in diameter).
The first line of management of primary spontaneous pneumothorax is intercostal tube
insertion .that provide management of this case and only recurrent or persisting cases need
further surgical management.
Surgical management of Primary spontaneous pneumothorax is usually indicated in patients with
recurrent ipsi-lateral pneumothorax, first episode with occupational risk or persistent
air-leakage (more than 5 to 7 d), or prior contra-lateral pneumothorax. A first episode of a
Primary spontaneous pneumothorax is treated by observation if the area of pneumothorax is
<20% or by simple aspiration if >20%, but recurrences are frequent. For recurrent or
persisting pneumothorax, a more invasive surgical approach is indicated. The procedure can be
approached through open thoracotomy or video-assisted thoracic surgery.
There are two objectives in the surgical management of pneumothorax. The first widely
accepted objective is resection of blebs or the suture of apical perforations to treat the
underlying defect. The second objective is to create a pleural symphysis to prevent
recurrence. There is nearly zero mortality and very low major morbidity with either
video-assisted thoracic surgery or open approaches. Postoperative complications are low
(5%-10%), and usually minor and self-limited, including prolonged air-leakage, pleural
effusion or hemorrhage, wound infection or hematoma, pulmonary atelectasis or pneumonia.
The traditional open approach has gradually been replaced by minimally invasive
video-assisted thoracic surgery in the diagnosis and treatment for patients with various
intrathoracic diseases, including the treatment of Primary spontaneous pneumothorax. The
outcomes of video-assisted thoracic surgery for patients with Primary spontaneous
pneumothorax are very good compared to conservative treatment and equal to those of open
thoracotomy. The video-assisted thoracic surgery approach has the benefits of less
postoperative pain, better wound cosmetics, shorter hospital stay and duration of drainage,
better functional recovery, better short and long term patient satisfaction, and equivalent
cost-effectiveness to the open approach.video-assisted thoracic surgery is recommended as the
first-line surgical treatment for patients with recurrent Primary spontaneous pneumothorax or
first episode of Primary spontaneous pneumothorax. However, the recommendation can only be
graded as B or C as there have been only a limited number of patients in relevant randomized
trials.
The risk of postoperative recurrence requiring re-operation for the video-assisted thoracic
surgery and surgical groups varies in different reported series. However, re-operation
following video-assisted thoracic surgery is more often required than that after open
thoracotomy, with a higher rate of both late recurrent pneumo-thorax and prolonged early
postoperative air-leakage.
video-assisted thoracic surgery for Primary spontaneous pneumothorax can be accomplished
mostly through three ports, but two or single port(s) with the use of single incision port
laparoscopic surgery (SILS) system has been reported in recent years. Endotracheal general
anesthesia with the use of a double or single lumen endotracheal tube is still recommended by
most reported series for Primary spontaneous pneumothorax patients undergoing video-assisted
thoracic surgery . video-assisted thoracic surgery procedures through local or epidural
anesthesia for patients with Primary spontaneous pneumothorax (the awake procedure) have been
reported The bullae/blebs in patients with Primary spontaneous pneumothorax can be managed
through video-assisted thoracic surgery by stapling and resection, no-knife stapling,
suturing, or endo-loop ligation. Pleurodesis is usually required in addition to
bullae/blebectomy for surgical management of patients with Primary spontaneous pneumothorax.
It can significantly decrease the risk of early air-leakage or late recurrence, which is
especially important for patients undergoing video-assisted thoracic surgery .
Since the surgical treatment for patients with Primary spontaneous pneumothorax has become
less invasive through video-assisted thoracic surgery in recent years, there have been many
published papers suggesting the use of this surgical intervention for patients with the first
Primary spontaneous pneumothorax There are still some reported series that do not agree with
the use of video-assisted thoracic surgery after the first Primary spontaneous pneumothorax.
Retrospective cost effective analysis has revealed that tube thoracostomy should be used at
first occurrence, followed by video-assisted thoracic surgical bullae/blebectomy and
pleurodesis in case of recurrence. However, these studies were only based on single,
retrospective, and small case number analyses, and the patient satisfaction and quality of
life were not considered. video-assisted thoracic surgery will be expected as an option of
management for patients with their first Primary spontaneous pneumothorax. However, the
management of the first Primary spontaneous pneumothorax remains controversial because there
is still little high-quality evidence to guide the decision-making
