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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030200323

Registered date:25/01/2021

Safety and feasibility of bullectomy without postoperative chest tube for primary spontaneous pneumothorax

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPrimary spontaneous pneumothorax
Date of first enrollment01/01/2021
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Surgical procedure 1) Patients are placed in the lateral decubitus position under general anesthesia with single lung ventilation using a double lumen endotracheal tube. We usually use two different approaches, uniport or a transareolar approach, according to the patient's request. In the uniport approach, a 2.5-cm incision at the fifth intercostal space of the anterior axillary line is made. In the transareolar approach, a 5-mm arc incision is made for the forceps port at the upper edge of the areola; a 2-cm arc incision for stapling is made at the lower part of the areola through the fourth intercostal space. 2) A 5-mm flexible type of thoracoscope is used to explore the thoracic cavity. Visceral blebs or bullae are excised using an Endostapler. 3) The lung is immersed in warm sterile saline, ventilated at a maximum inspiratory pressure of 15 cmH2O, and examined for air leaks. If there is an air leak in this sealing test, this patient will be excluded from the study. 4) Subsequently, polyglycolic acid felt is applied to the staple lines using fibrin glue sealant to prevent any postoperative air leaks and reduce the recurrence rate. 5) A 20-Fr trocar catheter is placed in the thoracic cavity with continuous suction (7 cmH2O). 6) Patients are returned to the supine position after surgery. We check the lung expansion using a routine portable chest X-ray before awakening the patient from anesthesia. Confirming that the lung expansion is good and that there is no air leak, we remove the chest tube immediately after extubation in the operating room. If there are air leaks during this time, the patient will be excluded from the study, and the chest tube will be left in place. Postoperative day 1 We assess wound pain using a numerical rating scale (NRS) the next morning. After checking lung expansion by a chest X-ray, the patient will be discharged. Postoperative day 7 We assess the wound pain using a numerical rating scale and check lung expansion by a chest X-ray.

Outcome(s)

Primary OutcomeIncidence of pneumothorax requiring chest tube reinsertion
Secondary OutcomePostoperative hospitalization Postoperative pain score

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum< 50age old
GenderBoth
Include criteriaPrimary spontaneous pneumothorax patients scheduled for surgery at our institution Written, informed consent has been obtained.
Exclude criteriaAge over 50 years Secondary pneumothorax Bilateral simultaneous surgery Dense pleural adhesions (more than one lobe) Air leak intraoperative sealing test Blood loss over 50 ml Air leaks from the end of the surgery to awakening from anesthesia

Related Information

Contact

Public contact
Name Natsumi Matsuura
Address 389-1 Asakura, Maebashi City, Gunma Gunma Japan 371-0811
Telephone +81-27-265-3333
E-mail nmori1130@gmail.com
Affiliation Japanese Red Cross Maebashi Hospital
Scientific contact
Name Natsumi Matsuura
Address 389-1 Asakura, Maebashi City, Gunma Gunma Japan 371-0811
Telephone +81-27-265-3333
E-mail nmori1130@gmail.com
Affiliation Japanese Red Cross Maebashi Hospital