Prospective randomized trial comparing buttressed versus nonbuttressed stapling in patients undergoing pulmonary...

Area of Science:

• Thoracic Surgery
• Surgical Innovation
• Pulmonary Medicine

Background:

• Pulmonary lobectomy carries a risk of air leaks, a common complication.
• Buttressed staplers, featuring polyglycolic acid sheets, were developed to mitigate this risk.
• Evaluating the efficacy of buttressed stapling in reducing air leaks is crucial for patient outcomes.

Purpose of the Study:

• To assess the effectiveness of buttressed stapling versus conventional stapling in reducing air leaks after pulmonary lobectomy.
• To compare the frequency and duration of intraoperative and postoperative air leaks between the two stapler types.

Main Methods:

• A prospective, randomized, phase III clinical trial was conducted.
• Patients undergoing pulmonary lobectomy were assigned to either a buttressed stapler group or a conventional non-buttressed stapler group.
• The primary endpoint was the frequency of intraoperative air leaks.

Main Results:

• No significant difference in the overall frequency or duration of air leaks was observed between the buttressed and non-buttressed stapler groups.
• However, buttressed stapling significantly reduced the incidence of air leaks originating from stapler holes (2% vs. 20%, p=0.016).
• The study was terminated early due to manufacturer recall of the buttressed stapler following reports of serious adverse events.

Conclusions:

• The overall efficacy of buttressed stapling in preventing air leaks during pulmonary lobectomy was not definitively established in this trial.
• Buttressed stapling demonstrated a significant benefit in preventing air leaks specifically from stapler holes.
• Further investigation into the safety and efficacy of buttressed stapling devices is warranted, considering the reported adverse events.