BACKGROUND: A colorectal anastomotic leak can be life-threatening. We have assessed the feasibility of a new intraluminal biodegradable bypass device that we designed to avoid anastomotic leakage and the necessity of a temporary stoma. METHODS: Fifteen patients underwent colorectal surgery. Before performing the anastomosis in a standard way, the C-Seal (Polyganics BV, Groningen, The Netherlands) was glued to the anvil of the circular stapler. Consequently, the bypass was fixated in the staple row just proximal of the simultaneously made anastomosis. A water-soluble contrast enema was performed after 1 week. RESULTS: The sheath was well compatible with the standard stapler device and easy to use. All donuts remained intact. No radiologic or clinical leaks were observed after surgery. CONCLUSIONS: This pilot study shows that the C-Seal can be applied successfully in colorectal surgery. Further investigation with large numbers of patients is now necessary to assess the efficacy of the C-Seal as a protective device.
BACKGROUND: A colorectal anastomotic leak can be life-threatening. We have assessed the feasibility of a new intraluminal biodegradable bypass device that we designed to avoid anastomotic leakage and the necessity of a temporary stoma. METHODS: Fifteen patients underwent colorectal surgery. Before performing the anastomosis in a standard way, the C-Seal (Polyganics BV, Groningen, The Netherlands) was glued to the anvil of the circular stapler. Consequently, the bypass was fixated in the staple row just proximal of the simultaneously made anastomosis. A water-soluble contrast enema was performed after 1 week. RESULTS: The sheath was well compatible with the standard stapler device and easy to use. All donuts remained intact. No radiologic or clinical leaks were observed after surgery. CONCLUSIONS: This pilot study shows that the C-Seal can be applied successfully in colorectal surgery. Further investigation with large numbers of patients is now necessary to assess the efficacy of the C-Seal as a protective device.
Authors: Sami A Chadi; Abe Fingerhut; Mariana Berho; Steven R DeMeester; James W Fleshman; Neil H Hyman; David A Margolin; Joseph E Martz; Elisabeth C McLemore; Daniela Molena; Martin I Newman; Janice F Rafferty; Bashar Safar; Anthony J Senagore; Oded Zmora; Steven D Wexner Journal: J Gastrointest Surg Date: 2016-09-16 Impact factor: 3.452
Authors: Ilsalien S Bakker; Annelien N Morks; Henk O Ten Cate Hoedemaker; Johannes G M Burgerhof; Henri G Leuvenink; Rutger J Ploeg; Klaas Havenga Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102
Authors: Annelien N Morks; Klaas Havenga; Henk O ten Cate Hoedemaker; Jeroen W A Leijtens; Rutger J Ploeg Journal: Int J Colorectal Dis Date: 2013-06-14 Impact factor: 2.571
Authors: Elahe Hadavi; Rick H W de Vries; Alexandra M Smink; Bart de Haan; Jeroen Leijten; Leendert W Schwab; Marcel H B J Karperien; Paul de Vos; Pieter J Dijkstra; Aart A van Apeldoorn Journal: J Biomed Mater Res B Appl Biomater Date: 2020-07-16 Impact factor: 3.368