Abdominal Wall Hernia in Complex Patients incidences, risk factors and timing of repair

This thesis consists of two parts: __part 1__ describes a new prosthesis for the treatment of large and complex incisional hernia. Furthermore the natural course and consequences of conservative treatment are described; __part 2__ focusses on three complex groups of patients with abdominal wall hernia. The treatment and risk factors for complications in premature infants with an inguinal hernia, kidney transplant recipients with incisional hernia, and patients with an abdominal aneurysm of the aorta are described

Mesh expansion as the cause of bulging after abdominal wall hernia repair

__Background__ Recurrence is the most important complication of abdominal wall reconstruction. It is pos

Emergency repair of inguinal hernia in the premature infant is associated with high direct medical costs

_Purpose:_ Inguinal hernia repair is frequently performed in premature infants. Evidence on optimal management and timing of repair, as well as related medical costs is still lacking. The objective of this study was to determine the direct medical costs of inguinal hernia, distinguishing between premature infants who had to undergo an emergency procedure and those who underwent elective inguinal hernia repair. _Methods:_ This cohort study based on medical records concerned premature infants with inguinal hernia who underwent surgical repair within 3 months after birth in a tertiary academic children’s hospital between January 2010 and December 2013. Two groups were distinguished: patients with incarcerated inguinal hernia requiring emergency repair and patients who underwent elective repair. Real medical costs were calculated by multiplying the volumes of healthcare use with corresponding unit prices. Nonparametric bootstrap techniques were used to derive a 95 % confidence interval (CI) for the difference in mean costs. _Results:_ A total of 132 premature infants were included in the analysis. Emergency surgery was performed in 29 %. Costs of hospitalization comprised 65 % of all costs. The total direct medical costs amounted to €7418 per premature infant in the emergency repair group versus €4693 in the elective repair group. Multivariate analysis showed a difference in costs of €1183 (95 % CI −1196; 3044) in favor of elective repair after correction for potential risk factors. _Conclusion:_ Emergency repair of inguinal hernia in premature infants is more expensive than elective repair, even after correction for multiple confounders. This deserves to b

Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study

Background and Aims: ENHANCEwas a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).Approach and Results: Patients were randomized 1:1:1 to oral seladelpar 5 mg (n= 89), 10 mg (n= 89), placebo (n= 87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67xupper limit of normal (ULN), >= 15% ALP decrease from baseline, and total bilirubin <= ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score >= 4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial. While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10mg: 78.2%) versus placebo (12.5%) (p < 0.0001). ALP normalization occurred in 5.4% (p= 0.08) and 27.3% (p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: -3.14 (p= 0.02); placebo: -1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% (p= 0.0008); 10 mg: 16.7% (p= 0.03); placebo: 4%]. There were no serious treatment-related adverse events.Conclusions: Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): Study protocol for a randomized controlled trial

Background: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. Methods: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at α 0.025). Both per-protocol and intention-to-treat analyses will be performed. Discussion: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly

Incidence, risk factors, and treatment of incisional hernia after kidney transplantation: An analysis of 1,564 consecutive patients

Background. The objective was to evaluate the incidence and treatment of incisional hernia after kidney transplantation and to identify potential risk factors. Methods. A retrospective cohort study was performed. All kidney transplant recipients between 2002 and 2012 were included. Two groups were identified: patients with and without incisional hernia. An analysis of risk factors for the development of incisional hernia was performed. Results. A total of 1,564 kidney recipients were included. Fifty patients (3.2%) developed incisional hernia. On univariate analysis, female sex (54 vs 35 %), body mass index (BMI) >30 kg/m(2) (38 vs 17%), concurrent abdominal wall hernia (30 vs 16%), multiple explorations of the ipsilateral iliac fossa (38 vs 19%), left iliac fossa implantation (36 vs 24%), history of smoking (72 vs 57%), and duration of the kidney transplantation procedure (210 vs 188 minutes) were associated with the development of incisional hernia (P30; HR 2.9), multiple explorations of the ipsilateral iliac fossa (HR 2.0), duration of operation (HR 1.007), and concurrent abdominal wall hernia (HR 2.3) were independent risk factors. Twenty-six of 50 patients (52%) underwent operative repair, of whom 9 (35 %) required emergency repair. Conclusion. The incidence of incisional hernia after kidney transplantation with a median follow-up of 59 months is 3.2%. Obesity (BAIT >30), female sex, concurrent abdominal wall hernias, history of smoking, duration of surgery, and multiple explorations were independent risk factors for the development of incisional hernia after kidney transplantation. Attempts at preventing incisional hernias based on these risk factors should be explored

Implementing a clinical pathway for hip fractures; Effects on hospital length of stay and complication rates in five hundred and twenty six patients

Purpose: Modern management of the elderly with a hip fracture is complex and costly. The aim of this study was to compare the treatment-related hospital length of stay (HLOS) before and after implementing a clinical pathway for patients undergoing hip fracture surgery. Methods: This was a retrospective, before-and-after study. The first period ranged from June 21, 2008 to November 1, 2009 (N=212), and the second was from January 7, 2010 to July 7, 2011 (N=314). The electronic hospital system and patients records were reviewed for demographics, HLOS, mortality, complications and readmissions. Results: In the first period 53 % had a femoral neck fracture, of which 57 % were treated with hemiarthroplasty. In the second period this was 46 % and 71 %. Pertrochanteric fractures were treated with a Gamma nail in 85 % in the first period, and in 92 % in the second period. The median HLOS decreased from nine to six days (p<0.001). For the hemiarthroplasty group HLOS decreased from nine to seven days (p<0.001); for internal fixation there was no significant difference (five versus six days, p=0.557) and after Gamma nailing it decreased from ten to six days (p<0.001). For mortality no statistically significant difference was found (6 % versus 5 %, p=0.698). Complications decreased for the Gamma nail group (44 % versus 31 %, p=0.049). Readmissions for the total group were not different (16 % versus 17 %, p=0.720). Conclusions: Implementing a clinical pathway for hip fractures is a safe way to reduce the HLOS and it improves the quality of care