Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

Abstract

OBJECTIVE:

The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy.

SUMMARY BACKGROUND DATA:

No randomized trial evaluating alginate staple-line reinforcement has been performed to date.

METHODS:

The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis.

RESULTS:

Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups.

CONCLUSIONS:

FOREseal did not demonstrate a significant advantage over standard treatment alone.

• Authors: Marco Alifano, Christophe Jayle, François Bertin, Pierre Magdeleinat, Yves Castier, Olivier Tiffet, Alain Bernard, François Tronc, Pierre-Yves Brichon, Pascal Dumont, Gilles Grosdidier, Antoine Dujon, Abel Grine, Helena Pereira, Anais Le Jeannic, Marie Amélie Vinet, Hassani MaOulida, Isabelle Durand-Zaleski, Marc Riquet, Gilles Chatellier, Jean-François Regnard, FOREseal Investigators
• Journal: Annals of surgery (Ann Surg) Vol. 265 Issue 1 Pg. 45-53 (01 2017) ISSN: 1528-1140 [Electronic] United States
• PMID: 28009728 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Alginates
• Biocompatible Materials
• Hexuronic Acids
• Tissue Adhesives
• Glucuronic Acid

Topics

• Absorbable Implants
• Adenocarcinoma (surgery)
• Adult
• Aged
• Aged, 80 and over
• Alginates (administration & dosage)
• Biocompatible Materials (administration & dosage)
• Carcinoma, Large Cell (surgery)
• Carcinoma, Squamous Cell (surgery)
• Female
• Glucuronic Acid (administration & dosage)
• Hexuronic Acids (administration & dosage)
• Humans
• Intention to Treat Analysis
• International Cooperation
• Lung Neoplasms (surgery)
• Male
• Middle Aged
• Pneumonectomy (methods)
• Pneumothorax (etiology, prevention & control)
• Postoperative Complications (prevention & control)
• Prospective Studies
• Single-Blind Method
• Small Cell Lung Carcinoma (surgery)
• Standard of Care
• Surgical Stapling
• Time Factors
• Tissue Adhesives (administration & dosage)
• Wound Closure Techniques