ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Randomized Trial Between Buttressed and Non Buttressed Stapling in Pulmonary Lobectomy|
- Frequency of intraoperative air leak [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Duration of chest drainage will vary from patient to patient.
- Frequency of intraoperative sealant use [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The need to use a sealant intraoperatively will be assessed for each patient during surgery.
- Incidence of intraoperative adverse events [ Time Frame: Day 0 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Discharge date will vary from patient to patient
|Study Start Date:||August 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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
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.