Staple Line Reinforcement Sealant
Problem: Gastrointestinal (GI) tract anastomoses are frequently performed to restore digestive function after damaged or diseased tissue has been removed from the GI tract. Colorectal or intestinal anastomoses are generally required after a neoplasm, or tumor, has been removed from the intestinal tract. Resection and anastomosis of the stomach have traditionally been used in the treatment of malignancy or ulcerative disease and has recently become even more prevalent as partial stomach resections are performed as a part of bariatric surgery.
Unfortunately, leakage rates in colorectal anastomosis may vary from 5 to 15% and mortality following leaks can range from 6 to 40%. Leakage is particularly dangerous since it is linked with an increased recurrence of malignancy, which has been attributed to spill of tumor cells through the anastomotic site. Additionally, formation of abscess and fistula due to dehiscence are a dreaded complication after colorectal anastomosis and are hard to treat. In stomach resection, complications related to the stapled resection or anastomosis may consist of bleeding (6 to 15% of cases) and leakage (1–5.5% of cases), with accompanying complications such as severe sepsis.
Anastomosis leakage is particularly likely with diseased tissue, where the tissue is often more fragile. In particular, inflammatory processes reduce tissue strength due to a reduction in the amount of tissue collagen. Additionally, edema may form due to manipulation or disease.
Solution: LifeSealTM GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.
Application of LifeSeal GITM onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GITM seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.
Competition: No liquid sealant is specifically approved for use in the reinforcement of staple-line junctions in gastrointestinal anastomoses as intestinal and stomach walls are very challenging substrates for adhesion.
Several types of non-adhesive or nominally adhesive staple line reinforcement materials are currently available. These materials must be assembled onto the intraluminal stapler in a precise manner prior to the stapling procedure, which may involve time-consuming manual trimming. Furthermore, the efficacy of these materials rely on proper function of the intraluminal stapler. In the case of partial misfiring of the stapler, this type of reinforcement materials will not prevent leakage. However, an adhesive sealant that is applied after the stapling procedure is completed will serve to prevent leakage even when the stapling process is imperfect.
* The product is not approved for marketing
Yo LSF, et al. Dig Surg 2006;23:283–291