Cast-OFF Trial: One Versus 4 to 5 Weeks of Plaster Cast Immobilization for Nonreduced Distal Radius Fractures: A Randomized Clinical Feasibility Trial.

BACKGROUND: Distal radius fracture is a common fracture of which the incidence appears to be increasing worldwide. This pilot study investigated whether 1 week of plaster cast is feasible for nonreduced (stable fractures including nondisplaced and displaced fractures) distal radius fractures. METHODS: The study was a multicenter randomized clinical feasibility trial including patients from regional acute care providers. Patients with a nonreduced distal radius fracture were included in the study. Nonreduced fractures meant intra-articular or extra-articular fractures and including nondisplaced and minimal displaced fractures (dorsal angulation less than 5°-10°, maximum radial shortening of 2 mm, and maximum radial shift of 2 mm) not needing a reduction. Forty Patients were included and randomized. After 1 week of plaster cast, patients were randomized to 1 of the 2 treatment groups: plaster cast removed (intervention group) versus 4 to 5 weeks of plaster cast (control group). RESULTS: The analysis shows no significant differences between the 2 groups in having less pain, better function after 6 weeks, and better overall patient satisfaction. No difference was shown in secondary displacement between the 2 groups (control 1 vs intervention 0). CONCLUSION: One week of plaster cast treatment for nonreduced distal radius fracture is feasible, preferred by patients, with at least the same functional outcome and pain scores. LEVEL OF EVIDENCE: According to the Oxford 2011 level of evidence, the level of evidence of this study is 2.

Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial.

OBJECTIVE: The aim of this study was to compare chronic postoperative inguinal pain (CPIP) in patients with an inguinal hernia after the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal Technique (TIPP). BACKGROUND: The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding CPIP with low recurrence rates. Two open preperitoneal techniques, TREPP and TIPP, were compared in a randomized clinical trial with the hypothesis of fewer patients with CPIP after TREPP due to complete avoidance of nerve contact. METHODS: Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Before the trial's start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events, and health-related quality of life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months, and 1 year. RESULTS: Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but CPIP at rest at 1 year was comparable: 1.9% after TREPP vs 1.4% after TIPP, P = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, P = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, P = 0.591). CONCLUSION: Both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1-year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation. TRIAL REGISTRATION: ISRCTN18591339.

Long-term clinical experience with laparoscopic ventral hernia repair using a ParietexTM composite mesh in severely obese and non-severe obese patients: a single center cohort study.

Background: The treatment of incisional and ventral hernias is associated with significant complications and recurrences, especially in severely obese patients. Recent studies have shown a reduced rate of surgical site infections and length of hospital stay in severely obese patients undergoing a laparoscopic ventral hernia repair.Aim: This study aims to describe the clinical experience in terms of efficacy and safety with laparoscopic ventral hernia repair using the ParietexTM Composite mesh (Covidien Sofradim Production, Trevoux, France) in severely obese patients (body mass index ≥35) compared with non-severe obese patients in a seven-year single-center cohort.Material and methods: All patients with a primary ventral or incisional hernia admitted to our hospital from 2006 until December 2012 who underwent a laparoscopic repair with the Parietex Composite mesh were included in this study. Pain scores using a numeric rating were collected prospectively 24-48 hours postoperatively. Patient data were retrospectively collected.Results: A total number of 210 patients were included; 173 with a BMI <35 and 37 with a BMI ≥35. Mean follow-up was 31 months. No statistically significant differences were found with regard to operation time, hospital stay, use of analgesics and postoperative complications. The long-term follow up recurrence rate in non-severely obese patients was 13% compared to 16% in severely obese patients (p = .60).Conclusion: Laparoscopic ventral and incisional hernia repair using the Parietex Composite mesh is feasible and safe in severely obese patients compared to non-severely obese patients.

Review of 58 patients with necrotizing fasciitis in the Netherlands.

BACKGROUND: Necrotizing fasciitis is a rare, life threatening soft tissue infection, primarily involving the fascia and subcutaneous tissue. In a large cohort of patients presenting with Necrotizing fasciitis in the Netherlands we analysed all available data to determine the causative pathogens and describe clinical management and outcome. METHODS: We conducted a retrospective, multicentre cohort study of patients with a necrotizing fasciitis between January 2003 and December 2013 in an university medical hospital and three teaching hospitals in the Netherlands. We only included patients who stayed at the Intensive Care Unit for at least one day. RESULTS: Fifty-eight patients were included. The mortality rate among those patients was 29.3 %. The central part of the body was affected in 28 patients (48.3 %) and in 21 patients (36.2 %) one of the extremities. Most common comorbidity was cardio vascular diseases in 39.7 %. Thirty-nine patients (67.2 %) were operated within 24 h after presentation. We found a type 1 necrotizing fasciitis in 35 patients (60.3 %) and a type 2 in 23 patients (39.7 %). CONCLUSIONS: Our study, which is the largest study in Europe, reaffirmed that Necrotizing fasciitis is a life threatening disease with a high mortality. Early diagnosis and adequate treatment are necessary to improve the clinical outcome. Clinical awareness off necrotizing fasciitis remains pivotal.

Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure.

BACKGROUND: Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair. METHODS: The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients' perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN18591339.