13 research outputs found

    Innovative appliance for colostomy patients: an interventional prospective pilot study

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    International audienceBackground The control of body waste emptying is a constant research topic in stoma care. The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance. Methods An interventional prospective non-comparative pilot study was conducted in seven French centers. The study device is a new type of two-piece appliance including a base plate and a ``capsule cap'' (CC) composed of a capsule cover and a folded collecting bag. The device gently seals the stoma to provide stoma output control. When the bowel movement pressure increases the patient may control the deployment of the folded bag and collect stools. Patients with left-sided colostomy all using a flat appliance, were enrolled in a 2-week trial. Outcome measures were type of CC removal and peristomal fecal leaks while wearing the device. Results Of 30 patients (females 66.7%), with left-sided colostomy (permanent 76.7%), 23 (76.7%) completed the 2-week trial. A total of 472 CC changes were analyzed. Efficacy: of 404 (85.5%) CC changes reported in diaries, 302 (74.8%) were linked with stool and/or gas. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. No leaks around the appliance were observed in 400 (85.3%) changes. Safety: no serious adverse event occurred. Peristomal skin was not modified during the trial. Conclusions In the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable

    Safety and long-term outcome of a new concept for surgical adhesion-reduction strategies (Prevadh): a prospective, multicenter study.

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    International audienceBACKGROUND/AIMS: No agent has been consistently effective in preventing formation of peritoneal adhesions and postoperative bowel obstruction after abdominal surgery. The aim of this prospective multicenter study was to assess clinical safety and efficiency of a new adhesion-reduction barrier METHODOLOGY: Between September 2000 and April 2001, Prevadh was used in 78 patients. Operative procedures included 25 hepatic resections, 7 cholecystectomies, 32 colonic resections, 7 protectomies, 3 colostomy or recovery of continuity, 1 gynaecologic surgery and 3 others. Eleven patients were operated on by laparoscopy and 67 by laparotomy. RESULTS: The overall incidence of abscesses and wound complications was 2.4% and 9% respectively. After a mean follow-up of 36 months (range: 4-51 months), no patients experienced adverse events related to the adhesion barrier. Surgical reoperative procedures were performed in 10 patients for unrelated causes and no bowel obstruction occurred within the protected area. CONCLUSIONS: This study confirmed the safety of Prevadh adhesion barrier and suggested that this resorbable barrier might provide prevention from adhesion formation on peritoneal injured surfaces. However, a large randomized controlled trial remains necessary to prove the real effectiveness of adhesion barriers on clinical long-term outcome

    Indications for islet or pancreatic transplantation: Statement of the TREPID working group on behalf of the Societe francophone du diabete (SFD), Societe francaise d'endocrinologie (SFE), Societe francophone de transplantation (SFT) and Societe francaise de nephrologie - dialyse - transplantation (SFNDT)

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    While either pancreas or pancreatic islet transplantation can restore endogenous insulin secretion in patients with diabetes, no beta-cell replacement strategies are recommended in the literature. For this reason, the aim of this national expert panel statement is to provide information on the different kinds of beta-cell replacement, their benefit-risk ratios and indications for each type of transplantation, according to type of diabetes, its control and association with end-stage renal disease. Allotransplantation requires immunosuppression, a risk that should be weighed against the risks of poor glycaemic control, diabetic lability and severe hypoglycaemia, especially in cases of unawareness. Pancreas transplantation is associated with improvement in diabetic micro- and macro-angiopathy, but has the associated morbidity of major surgery. Islet transplantation is a minimally invasive radiological or mini-surgical procedure involving infusion of purified islets via the hepatic portal vein, but needs to be repeated two or three times to achieve insulin independence and long-term functionality. Simultaneous pancreas-kidney and pancreas after kidney transplantations should be proposed for kidney recipients with type 1 diabetes with no surgical, especially cardiovascular, contraindications. In cases of high surgical risk, islet after or simultaneously with kidney transplantation may be proposed. Pancreas, or more often islet, transplantation alone is appropriate for non-uraemic patients with labile diabetes. Various factors influencing the therapeutic strategy are also detailed in this report. (C) 2018 Published by Elsevier Masson SAS

    Pancreatic anastomosis after pancreatoduodenectomy: A position statement by the International Study Group of Pancreatic Surgery (ISGPS)

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    Background Clinically relevant postoperative pancreatic fistula (grades B and C of the ISGPS definition) remains the most troublesome complication after pancreatoduodenectomy. The approach to management of the pancreatic remnant via some form of pancreatico-enteric anastomosis determines the incidence and severity of clinically relevant postoperative pancreatic fistula. Despite numerous trials comparing diverse pancreatico-enteric anastomosis techniques and other adjunctive strategies (pancreatic duct stenting, somatostatin analogues, etc), currently, there is no clear consensus regarding the ideal method of pancreatico-enteric anastomosis. Methods An international panel of pancreatic surgeons working in well-known, high-volume centers reviewed the best contemporary literature concerning pancreatico-enteric anastomosis and worked to develop a position statement on pancreatic anastomosis after pancreatoduodenectomy. Results There is inherent risk assumed by creating a pancreatico-enteric anastomosis based on factors related to the gland (eg, parenchymal texture, disease pathology). None of the technical variations of pancreaticojejunal or pancreaticogastric anastomosis, such as duct-mucosa, invagination method, and binding technique, have been found to be consistently superior to another. Randomized trials and meta-analyses comparing pancreaticogastrostomy versus pancreaticojejunostomy yield conflicting results and are inherently prone to bias due to marked heterogeneity in the studies. The benefit of stenting the pancreatico-enteric anastomosis to decrease clinically relevant postoperative pancreatic fistula is not supported by high-level evidence. While controversial, somatostatin analogues appear to decrease perioperative complications but not mortality, although consistent data across the more than 20 studies addressing this topic are lacking. The Fistula Risk Score is useful for predicting postoperative pancreatic fistula as well as for comparing outcomes of pancreatico-enteric anastomosis across studies. Conclusion Currently, no specific technique can eliminate development of clinically relevant postoperative pancreatic fistula. While consistent practice of any standardized technique may decrease the rate of clinically relevant postoperative pancreatic fistula, experienced surgeons can have lower postoperative pancreatic fistula rates performing a variety of techniques depending on the clinical situation. There is no clear evidence on the benefit of internal or external stenting after pancreatico-enteric anastomosis. The use of somatostatin analogues may be important in decreasing morbidity after pancreatoduodenectomy, but it remains controversial. Future studies should focus on novel approaches to decrease the rate of clinically relevant postoperative pancreatic fistula with appropriate risk adjustment
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