Norrtalje

Researchers are evaluating treatments for elderly patients aged 75 and older who have an undisplaced femoral neck fracture (uFNF), classified as Garden I-II. The study compares whether replacing the hip (arthroplasty) reduces the need for further surgeries compared to preserving the hip with internal fixation. The goal is to lower the combined risk of needing reoperation or death within 1 to 2 years after surgery. Participants are randomly assigned to one of two treatment groups using the Swedish Fracture Register. One group receives arthroplasty, which may be either a hemi or total hip replacement depending on hospital routine based on patient age and mobility. The other group undergoes internal fixation, where the fracture is repaired using 2-3 screws, pins, or a sliding hip screw device, again according to hospital routine. Both treatments are devices applied to stabilize or replace the hip after fracture. During the study, participants are monitored for outcomes including the rate of additional surgeries and mortality up to 2 years after their initial operation. The main measure combines these two outcomes into a single variable to evaluate overall treatment success. The entire process is registered and randomized within the Swedish Fracture Register system, ensuring consistent follow-up and data collection.

This research aims to explore complications following the closure of a temporary loop ileostomy in patients who have undergone rectal cancer surgery. The study focuses on two main questions: whether the choice of anastomotic method affects the postoperative recovery, and whether using a prophylactic mesh during stoma site closure reduces the occurrence of hernias. The study is a prospective randomized multicenter trial involving patients with rectal neoplasm. Participants will be randomly assigned to receive either a stapled or hand-sewn anastomosis after ileostomy closure. Additionally, they may be randomized to have the stoma site closed using either a lightweight mesh placed under the muscle (retromuscular) or a long-lasting suture. The anterior fascia and skin are closed with running monofilament sutures, with the skin closure performed using a pursestring technique. During the study, researchers will monitor participants for postoperative complications including small bowel obstruction within 30 days and stoma site hernia formation over two years. The assessments will gather data on healing and complications to evaluate the impact of the different surgical techniques. Participant involvement includes follow-up for safety and effectiveness outcomes over the specified periods.

This trial evaluates the effects of a restrictive approach to giving non-resuscitation fluids in adults with septic shock, a serious condition caused by infection leading to dangerously low blood pressure. The study aims to assess both the potential benefits and harms of limiting these fluids compared to usual care. The trial focuses on adult patients diagnosed within 12 hours of intensive care unit (ICU) admission who require medication to support blood pressure. Participants are randomly assigned to one of two groups. The first group follows a protocol to reduce non-resuscitation fluids, where maintenance fluids are stopped if the patient has a positive fluid balance and is not dehydrated. Fluids and nutrition are carefully managed according to specific guidelines, including concentrated intravenous medications and nutrition support if needed. The second group receives usual care with fluids and medications given according to local routines, including maintenance fluids at a set dose unless otherwise specified. During the study, researchers monitor participants closely, focusing on mortality within 90 days after enrollment as the primary outcome. Fluid balance, medication use, nutrition, and patient condition are assessed to compare the two approaches. The study includes adult patients admitted to the ICU with septic shock and requires monitoring during their stay and follow-up to understand the effects of fluid management strategies on survival and safety.

Background: The generally accepted theory of why hemorrhoidal disease (HD) occurs is that the hemorrhoidal cushions slid down in the anal canal (muco-anal prolapse), which allows them to swell up. This creates problems with bleeding, leakage (soiling), itching and pain. Traditionally, severe HD is treated by surgical removal of the hemorrhoids, but the procedure is associated with long recovery time, pain and complications like stenosis and incontinence. Minimal invasive and hemorrhoid preserving surgery has gained popularity during the last two decades with new methods like Procedure for Prolapse and Hemorrhoids (PPH)/Stapled Anopexy and Transanal Hemorrhoidal Dearterialisation (THD)/Hemorrhoidal Artery Ligation and Recto Anal Repair (HAL/RAR). Several studies have shown, thought that mucopexy alone result in equally good result as THD/HAL-RAR. There are several ways to perform a mucopexy with different ways in how the sutures are applied and how many rows of sutures that are done. Other available methods focus on tissue destruction, for example sclerosing injections, laser, radio ablation, or methods with applied electricity that induce heat. These methods make the hemorrhoids to swell down but does not treat the muco-anal prolapse that are present in grade II and III hemorrhoids. PexyEazy® perform a mucopexy in a new, semi-automatic way with the benefit of reducing the cost and time of surgery and is estimated to be able to be conducted without the need of general anesthesia. Method: PexyEazy® is a single-use device for surgical treatment of internal HD grade II and III (according to the Goligher classification). It is based on the mucopexy method, but instead of applying the sutures by hand, the mucosa is folded by the device and then a loop of suture is introduced into the folded mucosa. When knots are applied, the hemorrhoids are lifted inwards, as the folded mucosa above the hemorrhoids is pulled together. Due to that the most proximal suture is longer and deeper and acts as an anchoring stich, the lifting motion is inwards, towards the deeper stitch. When the position of the hemorrhoids is normalized, the venous drainage is improved, and the hemorrhoids swell down, and symptoms disappears. PexyEazy® consists of five major parts: PexyEazy® examination proctoscope, handle with depth setting piston, light shuttle with a led lamp, PexyEazy® Mucopexy Device (MD) and the battery-pack. All parts are sterile, except the re-usable battery-pack. With the examination proctoscope, a correct position of the operation area is set by pushing a depth setting piston, that is part of the handle, towards the skin when the proctoscope is aligned with the dentate line. The handle is then transferred to the MD, which is inserted into the rectum until the depth- setting piston touches the skin, ensuring a correct position of the operation area. The MD have three operation areas that are positioned alongside the device at 3, 7, and 11 o'clock, which corresponds with the position of the three major internal hemorrhoids. Each operation area consists of 5 indentations, 4 smaller and one larger furthest in. The floor of the indentations has small holes, so when vacuum suction is applied within the device, the mucosa is sucked down into the indentations and thereby folding the mucosa above the hemorrhoids. A double needle is then pushed through the folded mucosa and docks with the ends of a loop of a suture that is stored in the suture cassette at the tip the tip of the device. When the needles are retracted, a loop of suture is introduced through the folded mucosa. The position of the sutures starts 10mm above the dentate line thanks to the settings done through the examination proctoscope and the depth setting piston. The sensation of pain is not present 10mm above the dentate line, which enables surgery without anesthesia. The stitches are 4mm wide, 3mm deep and 10mm long in the first four stitches and 6mm deep and 12mm long in the final stitch furthest in. The unit forming the walls of the indentations is divided into three longitudinal parts. When a supportive tray is removed the unit falls apart into three pieces and is removed, leaving the suture in the mucosa. Knots are then applied with a knot pusher, which pulls the folded mucosa together and the hemorrhoids are lifted inwards. The compressed mucosa is estimated to create multiple adhesion points/scar tissues that fixate the hemorrhoid in the new elevated position, ensuring a long-lasting result after the suture is absorbed (60-90 days). A special mucosa spatula is used to push out any protruding mucosa to make extraction of the device easier without damaging the tissue. Number of subjects: 31-35 patients The SCI-Pex study will evaluate the safety and performance of PexyEazy on patients with hemorrhoids grade II and III. For safety reasons will the first 6-10 patients undergo the procedure under general anesthesia and then the procedure will be done on awake patients (25) with 1 week, 3 months and 1 years follow up with questionnaires and a clinical examination after 3 months and 1 year to document result.

This research aims to evaluate whether adding vasopressin and steroids to adrenaline improves survival in patients who experience cardiac arrest while already hospitalized. This is a phase 3, randomized, placebo-controlled, double-blind clinical trial conducted at multiple centers over an estimated 3-4 year period. The study plans to enroll about 1400 patients to determine if survival increases from 9% to 14% with the additional treatments. Patients who have an in-hospital cardiac arrest and meet criteria for adrenaline administration according to current guidelines will be randomized. They will receive either adrenaline plus vasopressin and steroids (methylprednisolone and hydrocortisone) or adrenaline plus a placebo (sodium chloride). Vasopressin is studied for its potential to improve blood flow and brain oxygenation during cardiac arrest, while steroids may help reduce injury and support recovery. Because informed consent cannot be obtained during the cardiac arrest event, hospitalized men over 18 years and women over 50 years (except certain exclusions) will be asked for consent beforehand to participate if a cardiac arrest occurs. Participants will be closely monitored, and the primary outcome measured is survival at 30 days after cardiac arrest. The study will also track safety and treatment effects throughout the hospital stay and follow-up periods.