A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resectio
Not Applicable
- Conditions
- ung cancer
- Registration Number
- JPRN-UMIN000008301
- Lead Sponsor
- First Department of Surgery, Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with a history of chest injury or pulmonary lobectomy 2)Patients with non-curative resectable factors of pulmonary cancer such as pleural dissemination and malignant pleural effusion on opening the chest 3)Patients with active bacterial and/or fungal infections 4)Patients receiving continued systemic (oral or intravenous) steroids 5)Patients with uncontrolled diabetes mellitus (HbA1c > 8.0%) 6)Patients with impaired major organ function (CTCAE ver. 4.0 Grade ≥ 2) 7)Patients with a psychiatric disorder or psychiatric symptoms that would preclude participation in the study 8)Any other patients judged by the doctor in charge to be ineligible as subjects in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The success rate and results of sealing of pulmonary arteries (under 5 mm in diameter)
- Secondary Outcome Measures
Name Time Method The frequency of additional procedures to the sealed sites during surgery. The occurrence frequency of intraoperative and postoperative adverse events, the duration of drain placement, and the duration of hospitalization.