NCT00488904 (http://www.clinicaltrials.gov).

No abstract

Omega-3 fatty acids (n-3 FA) may have beneficial clinical and immune-modulating effects in surgical patients. In a randomized, double-blind, prospective, placebo-controlled trial, 148 patients referred for elective colorectal cancer surgery received an n-3 FA-enriched oral nutritional supplement (ONS) providing 2.0 g of eicosapentaenoic acid (EPA) and 1.0 g of docosahexaenoic acid (DHA) per day or a standard ONS for seven days before surgery. On the day of operation, there was a significant increase in the production of leukotriene B5 (LTB5) (p < 0.01) and 5-hydroxyeicosapentaenoic acid (5-HEPE) (p < 0.01), a significant decrease in the production of leukotriene B4 (LTB4) (p < 0.01) and a trend for a decrease in the production of 5-hydroxyeicosatetraenoic acid (5-HETE) (p < 0.1) from stimulated neutrophils in the active group compared with controls. There was no association between LTB4 values and postoperative complications. In conclusion, oral n-3 FA exerts anti-inflammatory effects in surgical patients, without reducing the risk of postoperative complications.

ObjectiveTo evaluate the long-term results of implantation of an artificial anal sphincter (AAS) for severe anal incontinence. Summary Background DataImplantation of an AAS is one of the options for treatment of anal incontinence when standard operations have failed. It is the only surgical option for treatment of anal incontinence in patients with neurologic disease that affects the pelvic floor and the muscles of the lower limb. MethodsSeventeen patients underwent implantation of an AAS before 1993. These patients have been followed and their continence status evaluated. ResultsTwo patients died of unrelated causes within the first 3 years after surgery, and in three patients the AAS was explanted because of infection. During the follow-up period, four patients had the AAS removed because of malfunction, and eight patients had a functioning AAS Ն5 years after the primary implantation. Five of these patients had revisional procedures, mainly because of technical problems in the early part of the study, when a urinary sphincter or slightly modified urinary sphincter was used. Continence at follow-up was good in four patients and acceptable in three, whereas one patient still had occasional leakage of solid stool. One patient had rectal emptying problems, which she managed by enema. ConclusionsAn AAS based on the same principles as the artificial urinary sphincter seems to be a valid alternative in selected patients when standard surgical procedures have failed or are unsuitable. Approximately half of the patients have an adequate long-term result. Infectious complications still present a problem, whereas mechanical problems are less frequent with the modification of the device now available.Treatment of severe anal incontinence by implantation of an artificial anal sphincter (AAS) was first reported by us in 1987, 1 and the first series were published in 1989 and 1992.2,3 The first patients were implanted with an unmodified urinary sphincter, but subsequently this device was modified to meet the demands of a bowel sphincter (higher closing pressure and increased strength of the cuff).Because production of the sphincter was suspended, only a few patients underwent implantation until 1996, when the device again became available to a few centers. Recently published results from these centers have confirmed our early positive evaluation of the method. 4 -6 The follow-up varied from 4 to 76 months in the first two of these series 4,5 and from 4 to 12 months in the last. We herein present the first long-term results with a follow-up of Ն5 years with an AAS. PATIENTS AND METHODSBetween 1987 and 1993, 17 patients (11 women and 6 men; median age 46 [range 32 to 65 years]) underwent implantation of the AAS. The first six patients received a urinary sphincter (AMS 800, American Medical Systems, Minneapolis, MN); the last 11 received a modified version of the urinary sphincter (the cuff-tab was strengthened, the cuffs were made wider, and the pressure-regulating balloon was enlarged so that a cuff pressure of up to 90 cm H...