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Background & Aims Fibrin glue is a therapeutic for fistulas that activates thrombin to form a fibrin clot, which mechanically seals the fistula tract. We assessed the efficacy and safety of a heterologous fibrin glue that was injected into the fistula tracts of patients with Crohn's disease (ClinicalTrials.gov No. NCT00723047). Methods This multicenter, open-label, randomized controlled trial included patients with a Crohn's disease activity index ≤250 and fistulas between the anus (or low rectum) and perineum, vulva, or vagina, that drained for more than 2 months. Magnetic resonance imaging or endosonography was performed to assess fistula tracts and the absence of abscesses. Patients were stratified into groups with simple or complex fistulas and randomly assigned to receive fibrin glue injections (n = 36) or only observation (n = 41) after removal of setons. The primary end point was clinical remission at week 8, defined as the absence of draining, perianal pain, or abscesses. At week 8, a fibrin glue injection was offered to patients who were not in remission. Results Clinical remission was observed in 13 of the 34 patients (38%) of the fibrin glue group compared with 6 of the 37 (16%) in the observation group; these findings demonstrate the benefit of fibrin glue (odds ratio, 3.2; 95% confidence interval: 1.1–9.8; P = .04). The benefit seemed to be greater in patients with simple fistulas. Four patients in the fibrin glue group and 6 in the observation group had adverse events. Conclusions Fibrin glue injection is a simple, effective, and well-tolerated therapeutic option for patients with Crohn's disease and perianal fistula tracts.

Moderate exercise has been shown to enhance proinflam matory cytokines with decrea sed infection in athletes and healthy volunteers. Knowle dge of exercise effects in tumor patients including colorectal carcinoma, however, is limited, but could be important to under stand potentially beneficial effects. We, therefore, investigated the influence of a moderate (ME) vs. low impact (LE) postoperative exercise progra m on cytokine response in patients with colorec tal cancer with special regard to IL-I ra and IL-6, as decreased IL-I ra and increased IL-6 recently have been found to be associated with tumor progression. PATIE NTS AND METHODS: Eighteen pts. with colorectal cancer were equally randomized into a ME or LE program after surgery and chemotherapy/radiation. ME consisted of bicycle exercise (100 W, 40 min/d) for 3 weeks, LE comprised a low impact gymnastics program of the same duration. Cytokines (lL-6, IL-I ra, IL-I b. tumor necrosis factor [TNF] , TNF recep tor I and II) were assessed before and at the end of the program using ELISA assays after stimulation with lipopolysaccharide and pokeweed mitogen. RESULTS: In ME pts. IL-Ira decreased from 30,397 pg/mL (18,03 5 70,028, median, range) to 22,639 (7,814 34,726) (p < 0.02), whereas IL-6 slightly increased (12,692 , 5,803 30,379 to 15,617, 7,634 26,356 ), decreasin g the IL-l ralIL-6 ratio form 2.39 to 1.44 . In LE pts. IL-I ra and IL-6 remained unchanged (27,217, 20,871 89,3 14; 8,340, 4,830 8,661), with IL-l ralIL-6-ratio 3.26. The remaining cytokines also changed only insignificantly. CONCLUSIONS: Our data sugges t that a ME program in contras t to LE may decrease antiinflammatory response (lLra), thus shifting the cytokine balance to a more prointlammatory state as retlected by the decreased IL-ralIL -6 ratio. Whethe r this effect, however, may be clinically beneficial, has to be investigated in further trials with clinical endpoints in addition to measuring cytokine response.