0000000000476625
AUTHOR
Jonas F Schiemer
Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome after rectal resection
Background Low anterior resection syndrome (LARS) is a frequent problem after rectal resection. Transanal irrigation (TAI) has been suggested as an effective treatment in patients who have developed LARS. This prospective RCT was undertaken to evaluate the effect of TAI as a prophylactic treatment to prevent symptoms of LARS. Methods Patients who had undergone ultralow rectal resection were randomized to start TAI on a daily basis, or to serve as a control with supportive therapy only after ileostomy closure. All patients were seen after 1 week, 1 month and 3 months, and the maximum number of defaecation episodes per day and night documented during follow-up. Wexner score, LARS score and Sh…
Electrical stimulation with motility analysis of five parts of the gastrointestinal tract ; First evaluation of an experimental protocol in a porcine model
Abstract Gastrointestinal (GI) motility disorders are frequent and clinically significant conditions with impairment of patient’s quality of life. Examples range from upper GI symptoms such as dysphagia and gastroparesis to lower GI manifestations, namely chronic-intestinal pseudo obstruction, diarrhea and constipation. Furthermore, postoperative motility disorders are common. Currently, available pharmacological or dietetic treatment options are limited. Since GI motility is based on myoelectric activity, electrical stimulation (ES) is a promising alternative. Numerous studies have demonstrated suitable pacing strategies and parameters in different GI segments. However, results of multiloc…
Research platform for medical device development to simplify translation to the market
New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products becomes a high economic risk. All this demands for a CE-marked platform, which offers the possibility to access the recorded data online or even directly the hardware during research applications, to bridge the gap. This paper describes how a CE-marked medical product can be extended by different interfaces to enable basic research or simplify first proof-of-concept studies thus optimizing prototype development in research projects, simplifying the documentation process and reducing the risk for market access.
Five-fold Gastrointestinal Electrical Stimulation With Electromyography-based Activity Analysis: Towards Multilocular Theranostic Intestinal Implants
Background/aims Motility disorders are common and may affect the entire gastrointestinal (GI) tract but current treatment is limited. Multilocular sensing of GI electrical activity and variable electrical stimulation (ES) is a promising option. The aim of our study is to investigate the effects of adjustable ES on poststimulatory spike activities in 5 GI segments. Methods Six acute porcine experiments were performed with direct ES by 4 ES parameter sets (30 seconds, 25 mA, 500 microseconds or 1000 microseconds, 30 Hz or 130 Hz) applied through subserosal electrodes in the stomach, duodenum, ileum, jejunum, and colon. Multi-channel electromyography of baseline and post-stimulatory GI electri…
Translational development and pre-clinical evaluation of prototype gastrointestinal mock-up devices: only robotic placement of plastic?
Background: The aim of this study was to address the vision of wireless theranostic devices distributed along the gastrointestinal (GI) tract by defining design requirements, developing prototype mock-ups, and establishing a minimally invasive surgical approach for the implantation process. Methods: Questionnaires for contextual analysis and use case scenarios addressing the technical issues of an implantable GI device, a possible scenario for implantation, preparation and calibration of a device, and therapeutic usage by professionals and patients were completed and discussed by an interdisciplinary team of surgeons, engineers, and product designers. Two acute porcine experiments were cond…
Robotic Setup Promises Consistent Effects of Multilocular Gastrointestinal Electrical Stimulation: First Results of a Porcine Study
<b><i>Background:</i></b> Electrical stimulation (ES) of several gastrointestinal (GI) segments is a promising therapeutic option for multilocular GI dysmotility, but conventional surgical access by laparotomy involves a high degree of tissue trauma. We evaluated a minimally invasive surgical approach using a robotic surgical system to perform electromyographic (EMG) recordings and ES of several porcine GI segments, comparing these data to an open surgical approach by laparotomy. <b><i>Materials and Methods:</i></b> In 5 acute porcine experiments, we placed multiple electrodes on the stomach, duodenum, jejunum, ileum, and colon. Three experime…
Motility analysis by means of video tracked markers
Abstract The motility of the gastrointestinal tract is crucial for digestive activity and dysfunction can lead to severe disease pattern. A method for analysing the motility is needed when treatment approaches shall be evaluated. Therefore markers attached to different locations on the stomach and the bowel of pigs are video tracked in this research study. The markers are designed to provide a high contrast and have an adhesive side for fixation. Above the operation field a video camera has been placed to film the markers during the procedure. To analyse the video data a special algorithm has been implemented. The algorithm requires a registration process at the beginning of each recording …