<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804385</url>
  </required_header>
  <id_info>
    <org_study_id>Pneumothoracic</org_study_id>
    <nct_id>NCT03804385</nct_id>
  </id_info>
  <brief_title>Surgical Management of Primary Spontaneous Pneumothorax</brief_title>
  <official_title>Primary Spontaneous Pneumothorax and Different Types of Surgical Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the different surgical management in patients with primary pneumothorax 0 Objective 1:&#xD;
      Identify risk factors that are predictive of the need for surgical intervention.&#xD;
&#xD;
        -  Objective 2: Determine the value of management strategies in terms of hospital stay&#xD;
&#xD;
        -  Objective 3: Assess outcomes and postoperative results including symptom relive ,or&#xD;
           recurrence or post-operative complications .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      pneumothorax is defined as air or gas accumulated in the pleural cavity. Spontaneous&#xD;
      pneumothorax can be classified as either primary or secondary. Primary spontaneous&#xD;
      pneumothorax , which is defined as a pneumothorax without underlying lung disease,&#xD;
      predominantly occurs in young, thin males. It is usually caused by ruptured pleural blebs or&#xD;
      bullae. Secondary spontaneous pneumothorax usually occurs in older people with underlying&#xD;
      pulmonary disease, such as emphysema or asthma, acute or chronic infections, lung cancer, and&#xD;
      congenital diseases including cystic fibrosis, catamenial pneumothorax , or&#xD;
      lymphangio-leiomyomatosis .&#xD;
&#xD;
      The age-adjusted incidence of Primary spontaneous pneumothorax is from 7.4 to 18 per 100 000&#xD;
      population per year in males, and from 1.2 to 6 per 100 000 population per year in females.&#xD;
      It usually occurs in tall, thin males of 10 to 30 years old. Less often does it occur in&#xD;
      people at the age of more than 40 years. Primary spontaneous pneumothorax might be associated&#xD;
      with some congenital disorders such as Marfan's syndrome, or some environmental factors such&#xD;
      as smoking. Primary spontaneous pneumothorax usually occurs at rest. Approximately 10% of&#xD;
      patients with Primary spontaneous pneumothorax have a positive family history. Smoking is&#xD;
      also regarded as a precipitating factor for Primary spontaneous pneumothorax. The relative&#xD;
      risk of pneumothorax ranged from 7 to 100 times higher in light to heavy smokers Most authors&#xD;
      believe that Primary spontaneous pneumothorax results from spontaneous rupture of a&#xD;
      sub-pleural bleb or bulla. However, only a portion of patients with Primary spontaneous&#xD;
      pneumothorax could be found with blebs or bullae in imaging or at the time of surgery. Other&#xD;
      mechanisms may be considered, such as increase in pleural porosity secondary to inflammation.&#xD;
      The development of bullae, blebs, or pleural porosity might be related to many factors, such&#xD;
      as distal airway inflammation, distal bronchial tree anomaly, disorders of connective tissue&#xD;
      formation, local ischemia, and malnutrition.&#xD;
&#xD;
      Primary spontaneous pneumothorax usually occurs at rest, and presents with acute onset of&#xD;
      local pleuritic chest pain accompanied by dyspnoea. This pain may be mild or severe, sharp&#xD;
      and steady ache in character, and usually resolves within 24 h even though pneumothorax still&#xD;
      exists. On physical examination, decreased air entry on auscultation, decreased chest wall&#xD;
      movement on inspection, hyper-resonance (tympanic) on percussion are most often detected in&#xD;
      patients with large pneumothorax (free air occupies more than 15% to 20% area of hemi&#xD;
      thorax). Reflex tachycardia can be found in most patients in response to discomfort or&#xD;
      circulating or respiratory compromise. Tension pneumothorax should be suspected if severe&#xD;
      tachycardia, cold sweating, hypotension, or cyanosis has developed. Blood gas analysis in&#xD;
      patients with large pneumothoraces may reveal increased alveolar-arterial difference in&#xD;
      oxygen partial pressure (PA-aO2) due to increased intrapulmonary shunt from the collapsed&#xD;
      lung.&#xD;
&#xD;
      Most Primary spontaneous pneumothorax cases are confirmed by upright posteroanterior chest&#xD;
      radiograph, which can be used to assess the pneumothorax size with good accuracy. A pleural&#xD;
      line with or without an air-fluid level can be seen in the chest radiograph, but sometimes it&#xD;
      is difficult to detect these signs, especially in patients with small pneumothoraces,&#xD;
      emphysema, or poor exposure of the film. Expiratory chest radiographs have no diagnostic&#xD;
      value for patients with Primary spontaneous pneumothorax.&#xD;
&#xD;
      Computed tomography (CT) of the chest can be used to detect patients with small penman-thorax&#xD;
      (less than 15% area of hemi thorax). In addition, CT can provide more detailed information to&#xD;
      assist in the subsequent management. Findings which can be noted include the number, size,&#xD;
      and location of bullae/blebs (ipsi- or contra-laterally), as well the possibilities of&#xD;
      pleural adhesion, pleural fluid accumulation, and possible underlying pulmonary diseases. For&#xD;
      more than 90% of patients with Primary spontaneous pneumothorax, pathological lung changes&#xD;
      can be detected by CT. The most common type is few (n&lt;5) and small (&lt;2 cm in diameter) blebs,&#xD;
      followed by mixed blebs and bullae (&gt;2 cm in diameter).&#xD;
&#xD;
      The first line of management of primary spontaneous pneumothorax is intercostal tube&#xD;
      insertion .that provide management of this case and only recurrent or persisting cases need&#xD;
      further surgical management.&#xD;
&#xD;
      Surgical management of Primary spontaneous pneumothorax is usually indicated in patients with&#xD;
      recurrent ipsi-lateral pneumothorax, first episode with occupational risk or persistent&#xD;
      air-leakage (more than 5 to 7 d), or prior contra-lateral pneumothorax. A first episode of a&#xD;
      Primary spontaneous pneumothorax is treated by observation if the area of pneumothorax is&#xD;
      &lt;20% or by simple aspiration if &gt;20%, but recurrences are frequent. For recurrent or&#xD;
      persisting pneumothorax, a more invasive surgical approach is indicated. The procedure can be&#xD;
      approached through open thoracotomy or video-assisted thoracic surgery.&#xD;
&#xD;
      There are two objectives in the surgical management of pneumothorax. The first widely&#xD;
      accepted objective is resection of blebs or the suture of apical perforations to treat the&#xD;
      underlying defect. The second objective is to create a pleural symphysis to prevent&#xD;
      recurrence. There is nearly zero mortality and very low major morbidity with either&#xD;
      video-assisted thoracic surgery or open approaches. Postoperative complications are low&#xD;
      (5%-10%), and usually minor and self-limited, including prolonged air-leakage, pleural&#xD;
      effusion or hemorrhage, wound infection or hematoma, pulmonary atelectasis or pneumonia.&#xD;
&#xD;
      The traditional open approach has gradually been replaced by minimally invasive&#xD;
      video-assisted thoracic surgery in the diagnosis and treatment for patients with various&#xD;
      intrathoracic diseases, including the treatment of Primary spontaneous pneumothorax. The&#xD;
      outcomes of video-assisted thoracic surgery for patients with Primary spontaneous&#xD;
      pneumothorax are very good compared to conservative treatment and equal to those of open&#xD;
      thoracotomy. The video-assisted thoracic surgery approach has the benefits of less&#xD;
      postoperative pain, better wound cosmetics, shorter hospital stay and duration of drainage,&#xD;
      better functional recovery, better short and long term patient satisfaction, and equivalent&#xD;
      cost-effectiveness to the open approach.video-assisted thoracic surgery is recommended as the&#xD;
      first-line surgical treatment for patients with recurrent Primary spontaneous pneumothorax or&#xD;
      first episode of Primary spontaneous pneumothorax. However, the recommendation can only be&#xD;
      graded as B or C as there have been only a limited number of patients in relevant randomized&#xD;
      trials.&#xD;
&#xD;
      The risk of postoperative recurrence requiring re-operation for the video-assisted thoracic&#xD;
      surgery and surgical groups varies in different reported series. However, re-operation&#xD;
      following video-assisted thoracic surgery is more often required than that after open&#xD;
      thoracotomy, with a higher rate of both late recurrent pneumo-thorax and prolonged early&#xD;
      postoperative air-leakage.&#xD;
&#xD;
      video-assisted thoracic surgery for Primary spontaneous pneumothorax can be accomplished&#xD;
      mostly through three ports, but two or single port(s) with the use of single incision port&#xD;
      laparoscopic surgery (SILS) system has been reported in recent years. Endotracheal general&#xD;
      anesthesia with the use of a double or single lumen endotracheal tube is still recommended by&#xD;
      most reported series for Primary spontaneous pneumothorax patients undergoing video-assisted&#xD;
      thoracic surgery . video-assisted thoracic surgery procedures through local or epidural&#xD;
      anesthesia for patients with Primary spontaneous pneumothorax (the awake procedure) have been&#xD;
      reported The bullae/blebs in patients with Primary spontaneous pneumothorax can be managed&#xD;
      through video-assisted thoracic surgery by stapling and resection, no-knife stapling,&#xD;
      suturing, or endo-loop ligation. Pleurodesis is usually required in addition to&#xD;
      bullae/blebectomy for surgical management of patients with Primary spontaneous pneumothorax.&#xD;
      It can significantly decrease the risk of early air-leakage or late recurrence, which is&#xD;
      especially important for patients undergoing video-assisted thoracic surgery .&#xD;
&#xD;
      Since the surgical treatment for patients with Primary spontaneous pneumothorax has become&#xD;
      less invasive through video-assisted thoracic surgery in recent years, there have been many&#xD;
      published papers suggesting the use of this surgical intervention for patients with the first&#xD;
      Primary spontaneous pneumothorax There are still some reported series that do not agree with&#xD;
      the use of video-assisted thoracic surgery after the first Primary spontaneous pneumothorax.&#xD;
      Retrospective cost effective analysis has revealed that tube thoracostomy should be used at&#xD;
      first occurrence, followed by video-assisted thoracic surgical bullae/blebectomy and&#xD;
      pleurodesis in case of recurrence. However, these studies were only based on single,&#xD;
      retrospective, and small case number analyses, and the patient satisfaction and quality of&#xD;
      life were not considered. video-assisted thoracic surgery will be expected as an option of&#xD;
      management for patients with their first Primary spontaneous pneumothorax. However, the&#xD;
      management of the first Primary spontaneous pneumothorax remains controversial because there&#xD;
      is still little high-quality evidence to guide the decision-making&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Intercostal tube in days</measure>
    <time_frame>2 weeks</time_frame>
    <description>last more in open thoracotomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of air leakage in days</measure>
    <time_frame>2 weeks</time_frame>
    <description>last more in intercostal tube than in open thoracotomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence after one year</measure>
    <time_frame>one year</time_frame>
    <description>by radiological intervention on after one year follow up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain score</measure>
    <time_frame>1 week</time_frame>
    <description>high pain score in open thoracotomy than in intercostal tube</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pneumothorax</condition>
  <arm_group>
    <arm_group_label>intercostal tube</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>insertion of intercostal tube is surgical operation used in pneumothorax</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intercostal tube</intervention_name>
    <description>surgical operation</description>
    <arm_group_label>intercostal tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presented with primary pneumothorax at Assiut University Hospital patients&#xD;
             above 18 years and less 40 years Male or Females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with other chest pathology including :&#xD;
&#xD;
          -  emphysema&#xD;
&#xD;
          -  asthma,&#xD;
&#xD;
          -  acute or chronic infections&#xD;
&#xD;
          -  lung cancer,&#xD;
&#xD;
          -  congenital diseases including( cystic fibrosis, catamenial pneumothorax, or&#xD;
             lymphangioleiomyomatosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Abdel-kader Osman Ahmed, MHD</last_name>
    <phone>+201062226639</phone>
    <email>osman@med.aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Ahmed Khalil Salama Ayyad, MHD</last_name>
    <phone>+201002001932</phone>
    <email>ayyad@aun.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine Assiut Univeresity</name>
      <address>
        <city>Assiut</city>
        <zip>71621</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mohamed Abdel-kader Osman Ahmed, MHD</last_name>
      <email>osman@med.aun.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Mohamed Ahmed Khalil Salama Ayyad, MHD</last_name>
      <phone>01002001932</phone>
      <email>ayyad@aun.edu.eg</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>School of Medicine Assiut Univeresity</name>
      <address>
        <city>Assiut</city>
        <zip>71621</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mohamed Abdel-kader Osman Ahmed, MHD</last_name>
      <email>osman@med.aun.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Mohamed Ahmed Khalil Salama Ayyad, MHD</last_name>
      <phone>01002001932</phone>
      <email>ayyad@aun.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>May 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>ahmed samir yussef</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804385
org study id: Pneumothoracic
nct id: NCT03804385
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 .
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of Intercostal tube in days
time frame: 2 weeks
description: last more in open thoracotomy
measure: Duration of air leakage in days
time frame: 2 weeks
description: last more in intercostal tube than in open thoracotomy
measure: recurrence after one year
time frame: one year
description: by radiological intervention on after one year follow up
measure: pain score
time frame: 1 week
description: high pain score in open thoracotomy than in intercostal tube
arm group label: intercostal tube
arm group type: Other
description: insertion of intercostal tube is surgical operation used in pneumothorax
intervention type: Procedure
intervention name: intercostal tube
description: surgical operation
arm group label: intercostal tube
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mohamed Abdel-kader Osman Ahmed, MHD
phone: +201062226639
email: osman@med.aun.edu.eg
last name: Mohamed Ahmed Khalil Salama Ayyad, MHD
phone: +201002001932
email: ayyad@aun.edu.eg
facility: 
contact: 
contact backup: 
facility: 
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: ahmed samir yussef
investigator title: Principal Investigator
mesh term: Pneumothorax