[Clinical trials with medical devices: lack of quality illustrated for faecal incontinence]. / Therapiestudien mit Medizinprodukten: Mangelnde Qualität illustriert anhand analer Inkontinenz.

BACKGROUND: Medical devices must be safe and functioning states the law. Treatments with medical devices need not be efficacious to be allowed. We investigated special requirements and problems arising from the law. METHODS: The market for medical devices is contrasted with that for drugs. The requirements of relevant laws are discussed. Finally, published clinical studies on anal incontinence are analysed with respect to their methodological quality. RESULTS: Clinical trials of medical devices for treat-ing anal incontinence are of poor methodological quality thus preventing evaluation of the devices' utility. CONCLUSION: Large, high quality clinical studies of the efficacy of medical devices for treating anal incontinence are urgently needed. Only such studies enable health technology assessment and comprehensible decisions on reimbursement by health insurance.

[3T-AI: a new treatment algorithm for anal incontinence with a higher evidence level]. / 3T-AI: Ein neuer, mit höherer Evidenz versehener Behandlungsalgorithmus bei analer Inkontinenz.

BACKGROUND: The evidence for conservative treatment of anal incontinence is poor. In our first publication [Schwandner et al. Dis Colon Rectum 2010; 53: 1007-1016] we demonstrated that a novel therapeutic concept, termed triple target treatment (3T), combining amplitude-modulated medium frequency stimulation and electromyography biofeedback (EMG-BF) was superior to EMG-BF alone. Questions about the required treatment duration and the relevant subgroups of patients with sphincter damage and damaged anal sensibility were not addressed. METHODS: We enrolled 158 patients with anal incontinence in this randomized study. Here, we -report on the important subgroup analyses of patients with and without sphincter damage and damaged anal sensibility for the endpoints Cleveland Clinic Score (CCS) and success record. Using the results of this study we propose a novel treatment algorithm which is open for discussion. RESULTS: In patients with sphincter damage, the median difference on the CCS from baseline to 9 months was 5 points higher for 3T than for EMG-BF (95 % confidence interval 0-8; p = 0.0168). While 47 % of the patients with sphincter damage became continent with 3T, only 18 % did with EMG-BF (p = 0.0036). Ten of 17 patients in the 3T group regained anal sensibility after 3 months stimulation. There was tendency towards improved continence in patients with neuropathy upon 3T treatment (p = 0.1219). CONCLUSIONS: 3T is superior to EMG-BF alone for patients with sphincter damage and neuropathic anal incontinence. It is a successful key element within our treatment algorithm, even in patients with sphincter damage and neuropathic anal incontinence.

[Continuous local wound infusion with local anesthetics : For thoracotomy and major abdominal interventions]. / Kontinuierliche lokale Wundinfusion mit Lokalanästhetika : Bei Thorakotomien und großen abdominellen Eingriffen.

Wound infusion with local anesthetics is a nearly 100 years old proven and secure analgesic method. Recently special wound infusion catheters have become available which can be placed intraoperatively into the wound under direct supervision of the surgeon to infuse local anesthetics and optimize postoperative analgesia. For thoracotomy this method was modified to improve its efficacy and the catheters are used to establish a continuous paravertebral intercostal nerve block (PVB). Many studies have confirmed the analgesic power of PVB which results in a pain reduction comparable to thoracic epidural analgesia (TEA) but without TEA-specific side-effects, in particular hypotension. The efficacy of continuous local wound infusion (CLWI) is less obvious for laparotomy. If fundamental preconditions for this loco-regional method are considered (indications, choice of catheter, local anesthetic dose) the laparotomy wound could also be suitable for the use of CLWI. According to the literature currently available CLWI is not associated with an increased risk of wound infections.