31 research outputs found

    Trials

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    BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.This research program is funded by the French Ministry of Health through Programme Hospitalier de Recherche Clinique 2016

    What are the Particularities of Pancreatic Surgery in the Cirrhotic Patient?

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    International audienceThe objective of this work was to review the entire literature on pancreatic surgery in order to best define the surgical indications and the specifics of their management. The bibliographic research was done on Pubmed over the period from January 1995 to June 2015, using French and English as the languages of publication. The two main indications discussed here are the management of cancer and chronic pancreatitis. Surgery in the cirrhotic patient exposes the patient to a higher risk of complications than in the non-cirrhotic patient. Child-Pugh and MELD scores should be used to assess risk and guide operative decision. Child-Pugh classes B and a MELD score value greater than 15 are associated with higher morbidity and mortality. However, if suitable selection is made of cirrhotic patients who are candidates for pancreatic surgery, long-term survival seems to be equivalent to the non-cirrhotic group. No risk factors for long-term survival have been reported. In conclusion, cirrhotic patients, candidates for pancreatic surgery must be correctly selected, cirrhosis exposes to a higher risk of postoperative morbidity and mortality

    Acute Urinary Retention and Urinary Tract Infection after Short-Course Urinary Drainage in Colon or High Rectum Anastomoses: Post Hoc Analysis of a Multicentre Prospective Database from the GRACE Group.

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    International audienceAIM: The aim was to define the risk factors for acute urinary retention (AUR) and urinary tract infections (UTIs) in colon or high rectum anastomosis patients based on the absence of a urinary catheter (UC) or the early removal of the UC (24\,h (43.1%) and 97 were excluded because the management of UC was unknown (1%). Among the 5244 colon or high rectum anastomoses patients included, AUR occurred in 5.2% and UTI occurred in 0.7%. UCs were in place for <24\,h in 2765 patients (52.7%) and 2479 did not have UCs in place (47.3%). Multivariate analysis showed that management of the UC was not significantly associated with the occurrence of AUR and that risk factors for AUR were male gender, ≥q65\,years old, having an American Society of Anesthesiologists score ≥q3 and receiving epidural analgesia. Conversely, being of male gender was a protective factor of UTI, while being ≥q65\,years old, having open surgery and receiving epidural analgesia were risk factors for UTIs. The management of the UC was not significantly associated with the occurrence of UTIs but the occurrence of AUR was a more significant risk factor for UTIs. CONCLUSION: UCs in place for <24\,h did not reduce the occurrence of AUR or UTI compared to the absence of UCs

    Management of bleeding peptic duodenal ulcer refractory to endoscopic treatment: surgery or transcatheter arterial embolization as first-line therapy? A retrospective single-center study and systematic review

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    International audienceBackground The objective of this study was to compare the results of transcatheter arterial embolization (TAE) with surgery in terms of efficacy in the context of bleeding duodenal ulcer (BDU) refractory to endoscopic treatment. Materials and methods From January 2006 to December 2016, all patients treated for a BDU refractory to endoscopic treatment were included in this observational, comparative, retrospective, single-center study. Primary endpoint was the overall success of treatment of BDU requiring surgical and/or TAE. The secondary endpoints were pre-interventional data, recurrence rates, feasibility of secondary treatment, morbidity and mortality of surgical and radiological treatment, intensive care unit and length of stay. A systematic review of the literature was performed to compare results of surgery and TAE. Results 59 out of 396 patients (14.9%) treated for BDU required embolization and/or surgery: 15 patients underwent surgery (group S) including 7 patients after embolization failure and 44 patients underwent TAE (group TAE). The overall treatment success in intention to treat (85.7% vs 67.3%), per protocol (80% vs 79.5%) and bleeding recurrence rates (20% vs 15.9%) were also identical. Mortality (14.2% vs 15.3%) was similar between the two groups. Our study data were pooled with data from eight published studies and suggest that surgery have significant increased overall success (68.3% vs. 55.4%, p < 0.005). Conclusion The overall success rate was in favour of surgery according our meta-analysis. Our single-center study highlights the fact that predictive factors for recurrent bleeding after TAE must be identified to select good candidates for TAE and/or surgery

    Proposal of a new classification of postoperative ileus based on its clinical impact-results of a global survey and preliminary evaluation in colorectal surgery

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    IF 2.426International audiencePURPOSE: There is no consensual definition of postoperative ileus (POI), which leads to a lack of reproducibility. The aims of this study were (i) to propose and evaluate a classification of postoperative ileus based on its consequences and (ii) to assess the reproducibility of the classification.METHODS: A national global survey was carried out according to the DELPHI method in order to create a classification of primary POI. The classification was subsequently tested on a cohort of patients who underwent colorectal surgery. Finally, a reproducibility test was performed in five teaching hospitals with junior and senior surgeons.RESULTS: A five-stage classification was proposed: grade A (least) to grade E (worst). For better differentiation, subcategories (D1/D2) were included. Overall, 173 patients were included who underwent colorectal surgery. Forty of them experienced primary postoperative ileus (23.1%). Grade A occurred in 10 cases, grade B in 10 cases, grade C in 14 cases, grade D1 in 2 cases, and grade D2 in 2 cases. POI-related death (grade E) occurred in 2 cases. Patients with grade A POI recovered their gastrointestinal function significantly faster than those with higher grades (p = 0.01), and were more likely to undergo laparoscopic surgery (p = 0.04). The Intraclass Correlation Coefficient (ICC) was 0.83 in the overall population, and 0.83 and 0.82 respectively in the junior and senior surgeon populations.CONCLUSION: This classification is easy to both use and reproduce. It will improve the reproducibility, evaluation, and assessment of POI. These preliminary results should be confirmed in a multi-centric international study

    L’embolisation précoce dans le traitement non opératoire des traumatismes fermés de la rate. Étude rétrospective multicentrique

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    articleAIM OF THE STUDY: Splenic artery embolization has been used as an adjunct to the non-surgical management of blunt splenic injury. No consensus on its indications has emerged from the literature. This multicentric study aimed to evaluate the results of this technique in France. PATIENTS AND METHODS: Between March 2000 and April 2006, 22 patients older than 15 years of age (mean age 29, range: 15-59) with splenicv rupture due to blunt trauma underwent splenic artery embolization in six Level I Trauma Centers in France. Splenic rupture was classified Moore II in 3 cases, Moore III in 12 cases, and Moore IV in 7 cases. Angiography was performed within 4 hours of admission in half of the cases. The main indications for splenic artery embolization were: extravasation of contrast medium on CT scan (10 cases, 45%); early pseudo-aneurysm (6 cases, 23%); hypotension despite fluid resuscitation and/or progressive need for transfusion (5 cases, 22%). RESULTS: There was no mortality. Nine patients experienced complications (41%) including 6 (27%) who developed left pleural effusion. Two patients eventually underwent splenectomy (one for persistent hemorrhage, one for splenic necrosis). The overall splenic salvage rate was 91%. CONCLUSION: Splenic artery embolization is a valuable techniche that hels to lower the rate of splenectomy for traumatic splenic rupture with relatively low morbidity
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