NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030210541

Registered date:07/01/2022

Safety and feasibility of wedge resection and intrathoracic tumor resection without postoperative chest tube

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedLung tumor, Primary spontaneous pneumothorax, Mediastinal tumor, Chest wall tumor
Date of first enrollment01/12/2021
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)After resection of targeted tumor, 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. A 20-Fr trocar catheter is placed in the thoracic cavity with continuous suction (7 cmH2O). 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 maximumNot applicable
GenderBoth
Include criteriaScheduled for non-anatomical lung resection Scheduled for intrathoracic tumor biopsy/resection Written, informed consent has been obtained.
Exclude criteriaDense pleural adhesions (more than one lobe) History of ipsilateral anatomical lung resection Air leak intraoperative sealing test Blood loss over 100 ml Underlying lung disease (sever emphysema, interstitial pneumonia, etc) Air leaks from the end of the surgery to awakening from anesthesia

Related Information

Contact

Public contact
Name Hitoshi Igai
Address 389-1 Asakura, Maebashi City, Gunma Gunma Japan 371-0811
Telephone +81-9028913877
E-mail hitoshiigai@gmail.com
Affiliation Japanese Red Cross Maebashi Hospital
Scientific contact
Name Hitoshi Igai
Address 389-1 Asakura, Maebashi City, Gunma Gunma Japan 371-0811
Telephone +81-272653333
E-mail hitoshiigai@gmail.com
Affiliation Japanese Red Cross Maebashi Hospital