Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection

Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection - Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016715

Enrollment

300

Registered

2015-03-05

Start date

2015-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Patients using Thopaz Conventional drainage group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have no history of ipsilateral lung surgery, scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy, and fulfill below criteria are eligible. 1)Patients scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy 2)More than 800 mL of predicted postoperative forced expiratory volume in one second (ppoFEV1) (ppoFEV1 = Preoperative FEV1 x (number of segment - number of segment to be resected)/number of segment) 3)Performance Status 0-1 (ECOG classification) 4)Above 20 years old 5)Consent from the patient for participating in the study is obtained

Exclusion criteria

Exclusion criteria: 1)Has previously undergone ipsilateral lung surgery 2)Has an active lung infection (bacterial infection or fungal infection) 3)Undergoing continuing systemic administration (oral or intravenous) of steroids 4)Complicated by uncontrolled diabetes mellitus (Uncontrolled: urinary glucose of 10 g or more per day or fasting blood glucose of 150 mg/dL or more even under insulin treatment) 5)Requiring anticoagulant therapy (continuous intravenous drip of heparin) in the perioperative period 6)Patient participation in the study is judged difficult due to complications related to a psychiatric disorder or psychological symptoms 7)Judged unsuitable for study participation by the investigator for any other reason

Design outcomes

Primary

Measure	Time frame
Duration of drain placement (days)	—

Secondary

Measure	Time frame
Percent occurrence of intraoperative air leak (at the time of the first postoperative leak test), frequency of intraoperative sealant use and its type, percent occurrence of postoperative air leak (at the time of entering postoperative recovery room or ICU), duration of postoperative air leak (days), frequency of postoperative pleurodesis, days of hospitalization (days), and percent occurrence of postoperative adverse events	—

Measure

Time frame

Percent occurrence of intraoperative air leak (at the time of the first postoperative leak test), frequency of intraoperative sealant use and its type, percent occurrence of postoperative air leak (at the time of entering postoperative recovery room or ICU), duration of postoperative air leak (days), frequency of postoperative pleurodesis, days of hospitalization (days), and percent occurrence of postoperative adverse events

—

Countries

Japan

Contacts

Public ContactKazuya Takamochi

Juntendo University School of Medicine General Thoracic Surgery

ktakamo@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026