Dublin 9

Researchers are evaluating the effects of epoetin alfa compared to a placebo in critically ill trauma patients who require mechanical ventilation. This phase III, randomized, double-blind trial aims to reduce death and severe disability six months after injury. The study will enroll 2,500 patients admitted to intensive care units (ICUs) with a primary trauma diagnosis in locations including Australia, New Zealand, Europe, and Saudi Arabia. Trauma can cause serious injuries that may lead to death or long-term disability despite current treatments, and epoetin alfa, a hormone stimulating red blood cell production, may have protective effects beyond this role. Participants will be randomly assigned to receive either epoetin alfa 40,000 IU via a subcutaneous injection or a placebo injection of sodium chloride 0.9%, both given as 1 mL pre-filled syringes. The treatment will be administered during the ICU stay following admission for trauma. The study monitors patients from the time of injury through ICU care and up to six months afterward to assess outcomes. During the study, patients will be closely monitored for survival and disability levels using the WHODAS 2.0 scale at six months after injury. Researchers will track various health parameters, including the severity of disability or death. The study includes detailed assessments during ICU care and a follow-up period to measure the combined proportion of patients who die or experience severe disability. Safety and response to treatment will be carefully evaluated throughout the trial period.

Researchers are evaluating the differences in patient well-being and reported outcomes after undergoing nipple-sparing mastectomy (NSM) performed either by robotic-assisted or conventional open surgery. This trial focuses on women with breast cancer or those at risk, who are candidates for immediate deep inferior epigastric perforator (DIEP) flap reconstruction. NSM preserves the nipple-areolar complex and is associated with better cosmetic results and satisfaction compared to more extensive mastectomy techniques. Although robotic NSM shows promising benefits in visibility, precision, and reduced scarring, there is limited high-quality evidence comparing it directly to open NSM regarding patient satisfaction and aesthetic outcomes. The study is a prospective, multicenter, single-blinded randomized controlled trial within an Irish cancer network. Participants are divided into two groups based on their reconstruction type: implant-based or DIEP flap reconstruction. Each group is randomly assigned to receive either robotic-assisted NSM performed through a single axillary incision or conventional open NSM using traditional incisions. Robotic procedures are centralized at a designated hub, while open procedures are done locally or centrally depending on reconstruction needs. This design ensures access to robotic surgery while maintaining surgical expertise and oncological safety. Participants will be followed for up to 12 months after surgery, during which patient-reported outcomes will be collected using validated tools such as Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale. Independent assessors blinded to treatment groups will evaluate aesthetic outcomes. The study will monitor patient satisfaction, body image, and quality of life measures to determine if robotic NSM offers meaningful improvements. Safety and oncological criteria are strictly maintained, and all candidates must meet specific clinical and radiological requirements to be eligible for nipple-sparing procedures.

Breast-conserving surgery is a common treatment for early-stage breast cancer or ductal carcinoma in situ (DCIS). The goal is to remove the tumor completely with clear margins of normal tissue. If cancer cells are found at the edge of the removed tissue (positive margins), a second surgery may be needed. This study evaluates whether using three-dimensional (3D) digital breast tomosynthesis during surgery improves margin assessment compared to the standard two-dimensional (2D) specimen mammography, which is done in the radiology department and has some limitations. Participants undergoing breast-conserving surgery are randomly assigned to either standard 2D specimen mammography or 3D digital breast tomosynthesis performed directly in the operating theatre using the Mozart 3D Specimen Radiography System. In both groups, the operating surgeon reviews images during surgery to decide if more tissue removal is needed. The 3D imaging offers reconstructed slices that may provide better margin visualization and help guide surgical decisions in real time. The standard 2D approach requires moving the specimen to radiology and offers limited depth information. During the study, researchers will monitor the final surgical margin status based on pathology reports within four weeks after surgery. They will compare the rate of positive margins between the two imaging methods. They will also assess secondary outcomes like the need for additional surgery, operating time, workflow efficiency, and cost-effectiveness. Participants provide informed consent and are followed through surgery and postoperative evaluation to collect these data.

Researchers are studying women with a history of breast cancer who are undergoing yearly surveillance mammography after breast-conserving surgery and radiotherapy. This trial aims to find the best order for taking mammography images to improve patient comfort and satisfaction. The study will also compare the quality of the images, the compression force used, and breast thickness during the procedure. Participants will be randomly assigned to one of four different sequences of mammography views involving the treated and untreated breasts. These sequences vary in the order of mediolateral oblique (MLO) and craniocaudal (CC) images taken. The mammography procedure follows standard care without additional imaging beyond these sequences. During the mammography visit, pain levels will be recorded immediately before and after the procedure using a visual scale. Patient satisfaction will be assessed right after mammography through a questionnaire. Image quality will be reviewed later by two radiologists. Compression force and breast thickness measurements will also be collected. A total of 400 women will participate over 2.5 years, and the study will analyze the results based on the initial assigned sequence.

Urinary incontinence commonly occurs after radical prostatectomy for prostate cancer and can greatly affect quality of life. Pelvic floor physiotherapy is often recommended to lessen post-operative incontinence, but referral processes and patient participation can vary. The PRO-ACT trial is a single-center, randomized controlled study assessing whether a structured pre-operative education combined with direct physiotherapy referral can reduce urinary incontinence following surgery compared to standard care. Participants will be randomly assigned to one of two groups. The control group receives standard care, including an educational video and a recommendation for physiotherapy with patient-initiated referral, without scheduled follow-up calls. The intervention group receives a one-on-one pre-operative education session by an Advanced Nurse Practitioner, a scheduled follow-up call 7 to 10 days after surgery, and direct referral to supervised pelvic floor physiotherapy. Participants will be followed up at 6 weeks and 3 months after surgery. Researchers will assess urinary pad usage over 24 hours at 3 months as the primary outcome, using a 7-day pad diary. Secondary outcomes include time to continence, quality of life measures, physiotherapy adherence, and rates of post-operative complications. This study aims to improve continence outcomes and patient support after prostatectomy.

Researchers are evaluating whether men and women with HER2-positive metastatic breast cancer can be successfully recruited and randomized to either routine central nervous system (CNS) magnetic resonance imaging (MRI) surveillance or standard care without routine CNS surveillance. This type of breast cancer carries a high risk of brain metastases, which cause serious symptoms and affect quality of life and survival. While new HER2 therapies have improved control of cancer outside the brain, CNS progression remains common, and routine brain imaging is usually done only after neurological symptoms appear. Observational data suggest early detection of brain metastases might improve outcomes, but it is unknown if a surveillance approach is feasible or acceptable to patients. All participants will have a baseline contrast-enhanced brain MRI. Those without CNS metastases will be randomly assigned to one of two groups: the surveillance group will have repeat brain MRIs at 6 and 12 months, while the standard-of-care group will receive no routine brain imaging unless clinically needed. Participants with CNS metastases at baseline will not be randomized but managed according to usual care. The study aims to recruit up to 193 patients and will consider the approach feasible if at least 69 patients consent to screening and randomization. Participants will be followed for 14 months from baseline. Researchers will track how many patients agree to join the study, how many have previously undetected CNS metastases, and how many develop brain metastases during follow-up. They will also record any symptomatic brain disease, treatments targeting CNS metastases like surgery or radiotherapy, changes in systemic cancer therapy, and survival. Recruitment methods and barriers will be studied to help plan future trials.