spontaneous pneumothorax
Conditions
Interventions
After the bulla causing the pneumotorax is resected by linear stapler, both edge of staple-line are ligated by polydioxanone sutures. Then, the staple-line is covered by "
press-sheet type Integran(R)(100x50mm size)"
, followed by fixtation of the sheet using the sutures on the staple edge. After the day after surgery, the drainage tube is removed when investigator identify the stop of air leakage and decrease of
Sponsors
Kanto Rosai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)The patients between 16 to 25 years old. (2)With the diagnosis of primary spontaneous pneumothorax. (3)With the operative criteria described below and with use of linear stapler to resect bullae. a)Cases in which relapse is repeated with conservative treatment b)Cases with prolonged air leakage more than 1 week by conservative treatment c)Cases combined with mild or moderate hemothorax d)Cases not to achieve enough expansion of lung by continuous suction drainage. e)Cases with social reason (ex. pilot, diver) (4)Meet all requirements described below by blood examination. a)WBC >3000 and <12,000 /mm^3 b)CRP <3.0 mg/dL c)Hb >8.0 g/dL d)Plt > 100,000 /mm^3 e)AST <100 IU/L f)ALT <100 IU/L g)T-bil <2.0 mg/dL h)Cr <1.5 mg/dL i)Alb > 3.0 g/dL (5)With ECOG PS score 0 or 1 (6)With consent to enroll the study (especially, consents are needed from both patient and his/her parent when patients are less than 20-year old).
Exclusion criteria
Exclusion criteria: (1)Secondary spontaneous pneumothorax patients (2)Synchronous bilateral pneumothorax patients (3)Patients with shock vital sign (Systolic blood pressure <80 mmHg and HR > 100 bpm) or with hemothorax more than 1,000 ml (4)With medical history of ipsilateral thoracic surgery. (5)Patients with hypersensitivity to bovine derived products (insulin, glucagon etc.) (6)Patients with pregnancy (7)Patients who are assessed by investigator as "inadequate for enrollment" .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence proportion of sheet-related adverse events. (Seat-related adverse events are defined as either A) Fever of 38 degree Celsius or more that continues for at least 2 days occurring by the end of protocol treatment B) Abnormal inflammatory reactions with WBC > 18000/mm^3 or CRP > 15 mg/dl occurring by the end of protocol treatment C) Postoperative acute empyema occurring within 30 days after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Postoperative recurrence rate of pneumothorax (2)Occurence proportion of newly occured bullae around resected site at 12 months after surgery | — |
Countries
Japan
Contacts
Public ContactHiroyuki Adachi
Kanto Rosai Hospital Department of General Thoracic Surgery
Outcome results
None listed