Preloop trial : study protocol for a randomized controlled trial

BackgroundA temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist.Method/DesignThe Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure. The main endpoints in this trial are infections at 30-day follow-up and the incidence of hernias clinically or on CT scan at 10months after closure of the stoma. The secondary endpoints are other complications within 30days of surgery graded with the Clavien-Dindo classification, reoperation rate, operating time, length of stay, quality of life measured with RAND-36, and incidence of hernia over a 5-year follow-up period. A total of 100 patients will be randomized in a 1:1 ratio.DiscussionThis is a pilot trial that will be undertaken to provide some novel evidence on the safety profile and efficiency of both synthetic mesh and biological implants for the prevention of incisional hernias after closure by temporary loop ileostomy. The hypothesis is that synthetic mesh is economical but equally safe and at least as effective as biological implants in hernia prevention and in contaminated surgical sites.Trial RegistrationClinicalTrials.gov, NCT03445936. Registered on 7 February 2018.Peer reviewe

Chimney Trial : study protocol for a randomized controlled trial

Background Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs. Methods/design The Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh (R)-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh. The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. Discussion The Chimney Trial aims to provide level-I evidence on PSH prevention.Peer reviewe

Inflammatory response following abdominal surgery and its modulation by recombinant human granulocyte colony-stimulating factor (rhG-CSF, filgrastim)

Abstract The effects of perioperative filgrastim (rhG-CSF) and surgery per se on the postoperative acute phase reaction were studied by assessing leukocyte functions, cytokine levels and tenascin-C (Tn-C) and procollagen propeptide (PINP, PIIINP) concentrations in different body fluid compartments in patients undergoing gastrointestinal surgery. Thirty consecutive patients were randomized to receive either filgrastim or placebo for five days, starting 12 hours before colorectal surgery. Filgrastim treatment led to marked neutrophilia with decreased neutrophil migration in peripheral blood but not in peritoneal fluid 48 hours postoperatively. Neutrophil phagocytosis and bacterial killing did not differ between the groups. Filgrastim caused increased postoperative expression of neutrophil CD11b/CD18 in blood but not in peritoneal fluid or wound fluid. CD11b/CD18 expression was higher in both wound fluid and peritoneal fluid than in blood in the placebo group. The expression of neutrophil CD62L was higher in blood than in peritoneal fluid or wound fluid in both groups. The serum concentration of interleukin (IL)-8 was lower in the filgrastim group 5 hours postoperatively. The concentrations of IL-1β, IL-6, transforming growth factor (TGF)-β and IL-10 did not differ between the groups. The cytokine levels were markedly higher locally in the wound and in the peritoneal cavity compared to circulating blood. No adverse events attributable to filgrastim were seen. Leukocyte counts, neutrophil and monocyte functions and the levels of IL-6, IL-8 and granulocyte colony-stimulating factor (G-CSF) were measured from 18 patients before and after colorectal surgery. Surgery caused an increase in neutrophil and monocyte counts along with lymphocytopenia. Neutrophil phagocytosis was decreased 4 and 24 hours postoperatively, but normalized after that. A distinct systemic cytokine response was seen postoperatively. In a study with 24 patients, Tn-C concentration increased in wound fluid during the first postoperative week after abdominal surgery. The Tn-C level was markedly higher in wound fluid than in serum

Hospitalisti kirurgisella vuodeosastolla:hyötyä saavutettavissa?

Tiivistelmä Hospitalisti on sairaalassa työskentelevä yhdyslääkäri, jolla on laaja näkemys potilaiden akuuttien ja pitkä­aikaisten ongelmien hoidosta. Hospitalistien määrä on lisääntynyt voimakkaasti mallin synnyinmaassa Yhdysvalloissa. Malli tähtää hoidon laadun parantamiseen ja jatkuvuuden turvaamiseen. Suomessa mallia on pilotoitu Oulun yliopistollisessa sairaalassa. Alalle aikoville on tarjolla lisäkoulutusohjelma.Abstract A hospitalist is a clinician in hospital medicine who specializes in managing a patient’s acute hospital care. This discipline grew in the USA out of the increasing complexity of patients requiring hospital care and the need for dedicated clinicians to oversee their management. During the last two decades the number of hospitalists in the USA has reached 50 000. The two largest review articles show that both hospital stay and costs diminished with no decline in the quality of care when the hospitalist concept was used. We conducted a pilot study concerning the use of hospitalists on a surgical ward. The results are promising and the hospitalist role also seems to fit into the Finnish health care system. The Faculty of Medicine at the University of Oulu is offering an advanced hospitalist training programme, which has not previously been available either in Finland or in any other European country. It lasts two years and prepares a new path to coordinating comprehensive healthcare of patients with more complex care needs

Johtajuuden kehittyminen moniammatillisessa sosiaali- ja terveydenhuollon johtamiskoulutuksessa

Abstrakti Sosiaali- ja terveydenhuollon organisaatioihin kohdistuvat muutospaineet ja organisaatioiden kompleksisuus vaativat johtajuuden jatkuvaa uudistumista. Tutkimuksen tarkoituksena on kuvailla moniammatilliseen sosiaali- ja terveysalan johtamiskoulutukseen osallistuneiden johtajien johtajuuden sisällön osa-alueiden kehittymistä heidän omasta näkökulmastaan. Tutkimusaineistona olivat koulutukseen osallistuvien koulutuksen aikana tuottamat johtajuuden kehittymistä kuvaavat kirjalliset portfoliot (n=21). Analyysissä soveltaen hyödynnettiin narratiivista menetelmää ja temaattista sisällön analyysiä. Analyysin tuloksena rakentui kolme johtajuuden kehittymisen kuvausta: 1. itsejohtajuuden kehittymisen kuvaus, 2. inhimillisten voimavarojen johtajuuden kehittymisen kuvaus ja 3. muutoksen ja kompleksisuuden johtajuuden kehittymisen kuvaus. Tutkimuksen perusteella johtajuuden sisällön osa-alueet kehittyivät monipuolisesti moniammatillisen johtamiskoulutuksen aikana. Etenkin itsejohtajuus kehittyi yksilöllisesti koulutuksen aikana. Myös ihmisten väliseen toimintaan keskittyvässä johtajuudessa tapahtui monipuolista kehittymistä. Johtajat havaitsivat kehittyneensä etenkin muutoksen ja kompleksisuuden johtajuuden saralla. Tutkimus tuotti lisää tietoa itsejohtajuuden sekä muutoksen ja kompleksisuuden johtajuuden kehittymisestä puolitoista vuotta kestäneen koulutuksen aikana. Johtajuuden kehittymisestä ja kehittymisprosesseista tarvitaan jatkossa syvällisempää ja monipuolisempaa tutkimustietoa