Skelleftea

Researchers are evaluating the effects of a postoperative rehabilitation program for patients undergoing surgical correction of abdominal rectus diastasis, a condition where the abdominal muscles separate. The study aims to determine if structured abdominal exercises after surgery improve abdominal wall function at three and twelve months and to compare connective tissue components in patients with this condition to healthy individuals. This randomized controlled trial is conducted in Sweden and sponsored by Ume University. Participants will all undergo surgery to correct the abdominal rectus diastasis by plication of the linea alba. They are randomly assigned to one of two groups one group follows a postoperative rehabilitation program designed by a physical therapist, while the other group is allowed to exercise freely without a structured program. Blood samples and tissue biopsies from skin, connective tissue, and rectus muscle are collected before and during surgery. Follow-up assessments occur at three and twelve months after surgery. During the study, participants will be evaluated using physical function tests such as the 5 times sit to stand test and repetitions of a 20-kilogram deadlift at three and twelve months post-surgery. They will also complete questionnaires assessing pain, disability, and pelvic floor distress. Safety and progress are monitored through clinical visits and sample collections. The total participation time covers pre-surgery, surgery day procedures, and follow-ups at three and twelve months.

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Researchers are studying complications after closing a temporary loop ileostomy in patients who had surgery for rectal cancer. The study aims to answer two main questions whether the choice of anastomotic method affects recovery after surgery, and if using a mesh to close the stoma site can reduce hernias. This is a prospective randomized trial involving multiple centers to explore these surgical techniques. Participants are randomly assigned to receive either a stapled anastomosis using a linear staple device or a hand-sewn anastomosis with a running monofilament suture. Additionally, there is an optional randomization to close the stoma site either with a lightweight mesh placed under the muscle or with a long-lasting suture. The skin and fascia are closed with running monofilament sutures, including a pursestring technique for the skin. During the study, researchers will monitor participants for postoperative bowel obstruction within 30 days and for stoma site hernias over 2 years. They will also assess other complications and hospital stay length within 30 days. Participants will undergo follow-up visits to evaluate these outcomes and ensure proper recovery. The total participation timeline includes short-term and long-term monitoring to capture relevant surgical results.

Researchers are evaluating a multimodal preoptimisation programme for patients with ventral hernia defects between four and eight centimeters wide. This randomized controlled trial compares this prehabilitation approach to surgery without structured preoptimisation, aiming to reduce complications three months after surgery. The study also explores molecular changes related to collagen metabolism by collecting tissue biopsies and blood samples around the time of surgery. Participants in the intervention group follow a home-based prehabilitation programme lasting at least three months before surgery. This programme targets physical inactivity, obesity, comorbidities, smoking, and alcohol use, and is designed for both rural and urban populations. The control group receives basic advice on physical activity and weight management during their preoperative consultation. During the study, researchers collect biopsies of skin, muscle, and fascia during surgery and take blood samples before and after surgery to analyze molecular effects. Participants will be monitored for complications up to three months postoperatively, with additional assessments at twelve months including pain, quality of life, aesthetic outcomes, hernia recurrence, physical activity, weight, and various laboratory tests. The total participation time covers preoperative optimization and follow-up visits extending up to one year after surgery.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.

Researchers are evaluating the effectiveness and safety of apixaban as a stroke prevention treatment in adults with stage 5 chronic kidney disease CKD who also have atrial fibrillation AF or atrial flutter AFL. This study compares apixaban to no anticoagulation to see if it reduces the risk of ischemic stroke without increasing fatal or brain bleeding events. The trial also examines all-cause mortality, cardiovascular events, and major bleeding risks in this patient group. Participants are randomly assigned to one of two groups one receiving apixaban 2.5 mg twice daily plus standard care, and the other receiving standard care without anticoagulation. The study is open-label and conducted over 12 to 72 months across around 50 sites in several European countries. Patients already on warfarin, apixaban, or low molecular weight heparin may join after stopping their current anticoagulation. Routine blood tests are done at inclusion. During the trial, participants will be monitored for ischemic stroke, intracranial or fatal bleeding, death, cardiovascular events, and major bleeding according to established criteria. Additional outcomes include thromboembolic events and kidney transplant-related complications. The study lasts up to 72 months per participant or until a set number of events occur. Safety and efficacy data are reviewed by independent boards throughout the study.