K Strigård1, T Oresland, J Rutegård, U Gunnarsson. 1. Department of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. Karin.Strigard@ki.se
Abstract
AIM: Several attempts have been made to construct a mechanical continent stoma without success. A system based on a titanium implant has been developed in an animal model. Following evaluation of this device in animals, the transcutaneous implant evacuation system (TIES) has now been tested in humans. METHOD: The implant consists of a titanium cylinder including a mesh and a plastic cap. This design allows the intestine and subcutaneous tissue to grow into the device. Four patients with inflammatory bowel disease underwent surgery. The indications for surgery were malfunctioning pouches or skin problems around the stoma. Following abdominal surgery, implantation of the device was made behind the external fascia with diversion of the ileum through the device to create a permanent stoma. RESULTS: Primary surgery was uncomplicated. Skin tissue growth into the implant was delayed in one case and one patient had impaired healing between intestine and the device. In these cases minor surgical correction was necessary. The tested cap design in the current device was inconvenient and needs to be further developed. No local infections occurred. CONCLUSION: This first clinical study of the TIES device has shown few device-related complications and no significant safety concerns. In our experience bridging of connective tissue between the intestine and skin is crucial for healing. Further development of the lid, the implant and the implantation method within clinical trials is necessary before the device can be introduced in general practice.
AIM: Several attempts have been made to construct a mechanical continent stoma without success. A system based on a titanium implant has been developed in an animal model. Following evaluation of this device in animals, the transcutaneous implant evacuation system (TIES) has now been tested in humans. METHOD: The implant consists of a titanium cylinder including a mesh and a plastic cap. This design allows the intestine and subcutaneous tissue to grow into the device. Four patients with inflammatory bowel disease underwent surgery. The indications for surgery were malfunctioning pouches or skin problems around the stoma. Following abdominal surgery, implantation of the device was made behind the external fascia with diversion of the ileum through the device to create a permanent stoma. RESULTS: Primary surgery was uncomplicated. Skin tissue growth into the implant was delayed in one case and one patient had impaired healing between intestine and the device. In these cases minor surgical correction was necessary. The tested cap design in the current device was inconvenient and needs to be further developed. No local infections occurred. CONCLUSION: This first clinical study of the TIES device has shown few device-related complications and no significant safety concerns. In our experience bridging of connective tissue between the intestine and skin is crucial for healing. Further development of the lid, the implant and the implantation method within clinical trials is necessary before the device can be introduced in general practice.