Early fixation versus conservative therapy of multiple, simple rib fractures (FixCon): protocol for a multicenter randomized controlled trial

Background: Multiple rib fractures are common injuries in both the young and elderly. Rib fractures account for 10% of all trauma admissions and are seen in up to 39% of patients after thoracic trauma. With morbidity and mortality rates increasing with the number of rib fractures as well as poor quality of life at long-term follow-up, multiple rib fractures pose a serious health hazard. Operative fixation of flail chest is beneficial over nonoperative treatment regarding, among others, pneumonia and both intensive care unit (ICU) and hospital length of stay. With no high-quality evidence on the effects of multiple simple rib fracture treatment, the optimal treatment modality remains unknown. This study sets out to investigate outcome of operative fixation versus nonoperative treatment of multiple simple rib fractures. Methods: The proposed study is a multicenter randomized controlled trial. Patients will be eligible if they have three or more multiple simple rib fractures of which at least one is disl

Risk of heart failure diminished thanks to stomach reduction in obesity

BACKGROUND: Obesity is a chronic disease and a risk factor for heart failure. In end-stage heart failure, heart transplantation may be the only available treatment option, but obesity is a contraindication for this treatment because of its unfavourable prognosis. Bariatric surgery and its subsequent weight loss may affect the indication for transplantation in patients with heart failure and morbid obesity.CASE DESCRIPTION: A 46-year-old patient with morbid obesity and heart failure underwent gastric sleeve resection in preparation of a heart transplantation. Without it, he would not have been considered eligible for transplantation because of his obesity. The bariatric intervention was also intended to use weight loss as a way to reduce the symptoms of his heart failure and to make rehabilitation possible. One year after surgery, the condition of the patient had improved so much that heart transplantation was no longer necessary.CONCLUSION: Bariatric surgery is safe for morbidly obese patients with severe heart failure and may sometimes even avoid heart transplantation.</p

Hartfalen afgenomen door maagverkleining bij obesitas

BACKGROUND: Obesity is a chronic disease and a risk factor for heart failure. In end-stage heart failure, heart transplantation may be the only available treatment option, but obesity is a contraindication for this treatment because of its unfavourable prognosis. Bariatric surgery and its subsequent weight loss may affect the indication for transplantation in patients with heart failure and morbid obesity. CASE DESCRIPTION: A 46-year-old patient with morbid obesity and heart failure underwent gastric sleeve resection in preparation of a heart transplantation. Without it, he would not have been considered eligible for transplantation because of his obesity. The bariatric intervention was also intended to use weight loss as a way to reduce the symptoms of his heart failure and to make rehabilitation possible. One year after surgery, the condition of the patient had improved so much that heart transplantation was no longer necessary. CONCLUSION: Bariatric surgery is safe for morbidly obese patients with severe heart failure and may sometimes even avoid heart transplantation

Risk of heart failure diminished thanks to stomach reduction in obesity

BACKGROUND: Obesity is a chronic disease and a risk factor for heart failure. In end-stage heart failure, heart transplantation may be the only available treatment option, but obesity is a contraindication for this treatment because of its unfavourable prognosis. Bariatric surgery and its subsequent weight loss may affect the indication for transplantation in patients with heart failure and morbid obesity.CASE DESCRIPTION: A 46-year-old patient with morbid obesity and heart failure underwent gastric sleeve resection in preparation of a heart transplantation. Without it, he would not have been considered eligible for transplantation because of his obesity. The bariatric intervention was also intended to use weight loss as a way to reduce the symptoms of his heart failure and to make rehabilitation possible. One year after surgery, the condition of the patient had improved so much that heart transplantation was no longer necessary.CONCLUSION: Bariatric surgery is safe for morbidly obese patients with severe heart failure and may sometimes even avoid heart transplantation.</p

Rib Fixation for Multiple Rib Fractures: Healthcare Professionals Perceived Barriers and Facilitators to Clinical Implementation

Background: Surgical stabilization of rib fractures (SSRF) is associated with improved respiratory symptoms and shorter intensive care admission in patients with flail chest. For multiple rib fractures, the benefit of SSRF remains a topic of debate. This study investigated barriers and facilitators of healthcare professionals to SSRF as treatment for multiple traumatic rib fractures. Methods: Dutch healthcare professionals were asked to complete an adapted version of the Measurement Instrument for Determinants of Innovations questionnaire to identify barriers and facilitators of SSRF. If ≥ 20% of participants responded negatively, the item was considered a barrier, and if ≥ 80% responded positively, the item was considered a facilitator. Results: Sixty-one healthcare professionals participated; 32 surgeons, 19 non-surgical physicians, and 10 residents. The median experience was 10 years (P25–P75 4–12). Sixteen barriers and two facilitators for SSRF in multiple rib fractures were identified. Barriers included lack of knowledge, experience, evidence on (cost-)effectiveness, and the implication of more operations and higher medical costs. Facilitators were the assumption that SSRF alleviates respiratory problems and the feeling that surgeons are supported by colleagues for SSRF. Non-surgeons and residents reported more and several different barriers than surgeons (surgeons: 14; non-surgical physicians: 20; residents: 21; p < 0.001). Conclusion: For adequate implementation of SSRF in patients with multiple rib fractures, implementation strategies should address the identified barriers. Especially, improved clinical experience and scientific knowledge of healthcare professionals, and high-level evidence on the (cost-) effectiveness of SSRF potentially increase its use and acceptance

Early fixation versus conservative therapy of multiple, simple rib fractures (FixCon):protocol for a multicenter randomized controlled trial

BackgroundMultiple rib fractures are common injuries in both the young and elderly. Rib fractures account for 10% of all trauma admissions and are seen in up to 39% of patients after thoracic trauma. With morbidity and mortality rates increasing with the number of rib fractures as well as poor quality of life at long-term follow-up, multiple rib fractures pose a serious health hazard. Operative fixation of flail chest is beneficial over nonoperative treatment regarding, among others, pneumonia and both intensive care unit (ICU) and hospital length of stay. With no high-quality evidence on the effects of multiple simple rib fracture treatment, the optimal treatment modality remains unknown. This study sets out to investigate outcome of operative fixation versus nonoperative treatment of multiple simple rib fractures.MethodsThe proposed study is a multicenter randomized controlled trial. Patients will be eligible if they have three or more multiple simple rib fractures of which at least one is dislocated over one shaft width or with unbearable pain (visual analog scale (VAS) or numeric rating scale (NRS) >6). Patients in the intervention group will be treated with open reduction and internal fixation. Pre- and postoperative care equals treatment in the control group. The control group will receive nonoperative treatment, consisting of pain management, bronchodilator inhalers, oxygen support or mechanical ventilation if needed, and pulmonary physical therapy. The primary outcome measure will be occurrence of pneumonia within 30days after trauma. Secondary outcome measures are the need and duration of mechanical ventilation, thoracic pain and analgesics use, (recovery of) pulmonary function, hospital and ICU length of stay, thoracic injury-related and surgery-related complications and mortality, secondary interventions, quality of life, and cost-effectiveness comprising health care consumption and productivity loss. Follow-up visits will be standardized and daily during hospital admission, at 14days and 1, 3, 6, and 12months.DiscussionWith favorable results in flail chest patients, operative treatment may also be beneficial in patients with multiple simple rib fractures. The FixCon trial will be the first study to compare clinical, functional, and economic outcome between operative fixation and nonoperative treatment for multiple simple rib fractures.Trial registrationwww.trialregister.nl, NTR7248. Registered May 31, 2018

Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease

BACKGROUND & AIMS: Therapies for perianal fistulas in patients with Crohn's disease are often ineffective in producing long-term healing. We performed a randomized placebo-controlled trial to determine the long-term efficacy and safety of a single local administration of allogeneic expanded adipose-derived stem cells (Cx601) in patients with Crohn's disease and perianal fistulas. METHODS: We performed a double-blind study at 49 hospitals in Europe and Israel, comprising 212 patients with Crohn's disease and treatment-refractory, draining, complex perianal fistulas. Patients were randomly assigned (1:1) to groups given a single local injection of 120 million Cx601 cells or placebo (control), in addition to the standard of care. Efficacy endpoints evaluated in the modified intention-to-treat population (randomly assigned, treated, and with 1 or more post-baseline efficacy assessment) at week 52 included combined remission (closure of all treated external openings draining at baseline with absence of collections >2 cm, confirmed by magnetic resonance imaging) and clinical remission (absence of draining fistulas). RESULTS: The study's primary endpoint, at week 24, was previously reported (combined remission in 51.5% of patients given Cx601 vs 35.6% of controls, for a difference of 15.8 percentage points; 97.5% confidence interval [CI] 0.5-31.2; P = .021). At week 52, a significantly greater proportion of patients given Cx601 achieved combined remission (56.3%) vs controls (38.6%) (a difference of 17.7 percentage points; 95% CI 4.2-31.2; P = .010), and clinical remission (59.2% vs 41.6% of controls, for a difference of 17.6 percentage points; 95% CI 4.1-31.1; P = .013). Safety was maintained throughout week 52; adverse events occurred in 76.7% of patients in the Cx601 group and 72.5% of patients in the control group. CONCLUSION: In a phase 3 trial of patients with Crohn's disease and treatment-refractory complex perianal fistulas, we found Cx601 to be safe and effective in closing external openings, compared with placebo, after 1 year. ClinicalTrials.gov no: NCT01541579