Randomized Controlled Trial to Evaluate the Prevention of Postoperative Adhesions by Applying Regenerated Oxidized Cellulose Sheets in Thoracic Surgery
- Conditions
- Pulmonary disease requiring surgery with incision of the parietal pleura.pulmonary diseases
- Registration Number
- JPRN-jRCT1032230271
- Lead Sponsor
- Suzuki Hidemi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Patients who meet all of the following conditions are eligible.
1) Adults 18 years of age or older at the time of consent.
2) ECOG performance status (PS) of 0-2.
3) Main organ function is preserved.
4) Patients undergoing initial surgery to the affected chest or thoracic cavity.
5) Patients who have been fully informed of the study and have given their informed and voluntary written consent to participate in the study.
Patients who meet any of the following conditions are not eligible.
1) Patients with a history of intraoperative thoracic drainage.
2) Patients with a history of inflammatory diseases including pneumonia on the surgical side.
3) Patients who may undergo a total lung resection or a combined chest wall resection at surgery.
4) Patients with dementia or other conditions that require surrogate consent.
5) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
6) Other patients who are judged by the principal investigator or subinvestigator to be inappropriate for the safe conduct of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of pleural adhesion findings on chest echography performed 4-12 weeks postoperatively
- Secondary Outcome Measures
Name Time Method 1) Postoperative wound infection<br>2) Postoperative aerial fistula<br>3) Prolonged aerial fistula<br>4) Delayed aerial fistula<br>5) Postoperative bleeding<br>6) Postoperative period of chest drain placement (days)