ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
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|ClinicalTrials.gov Identifier: NCT01241617|
Recruitment Status : Terminated (Covidien is conducting a voluntary recall of DuetTRS™ use in the thoracic cavity. IFU is revised to contraindicate use in adult and pediatric thoracic surgeries)
First Posted : November 16, 2010
Last Update Posted : January 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Disease||Device: Duet TRS Device: Endo GIA||Not Applicable|
Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.
Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.
Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: Duet TRS
Endo GIA with integrated Duet TRS
Device: Duet TRS
Endo GIA stapler with integrated Duet TRS
Other Name: Endo GIA stapler with integrated Duet TRS
Active Comparator: Endo GIA
Endo GIA stapler with Single Use Loading units
Device: Endo GIA
Endo GIA stapler with Single Use Loading Units
Other Name: Endo GIA stapler with Single Use Loading Units
- Frequency of intraoperative air leak [ Time Frame: Day 0 ]Occurence of intraoperative air leak will vary from patient to patient and will be recorded for all patients.
- Postoperative duration of air leak [ Time Frame: Month 1 (Average time period) ]Duration of air leak will vary from patient to patient. Published literature states a duration of greater than 7 days occurs in 15% of patients.
- Duration of chest drainage [ Time Frame: Month 1 (Average time period) ]Duration of chest drainage will vary from patient to patient.
- Frequency of intraoperative sealant use [ Time Frame: Day 0 ]The need to use a sealant intraoperatively will be assessed for each patient during surgery.
- Incidence of intraoperative adverse events [ Time Frame: Day 0 ]The occurence of adverse events during surgery will be recorded for each patient.
- Incidence of postoperative adverse events [ Time Frame: Month 1 (Average time period) ]Patients are not required to return to the clinic at a specific time point. Any adverse events that occur after discharge will be captured.
- Days of hospitalization [ Time Frame: Month 1 (Average time period) ]Discharge date will vary from patient to patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241617
|Junendo University School of Medicine|
|Principal Investigator:||Kenji Suzuki, MD||Juntendo University School of Medicine|