Clinical trials

This randomized controlled trial evaluates postoperative quality of recovery assessed with the Quality of Recovery-15 questionnaire in adult patients undergoing elective major urological surgery under opioid-free versus opioid-based general anesthesia. Opioid-free anesthesia is a multimodal anesthetic technique that avoids intraoperative opioids by combining non-opioid analgesic and sympatholytic agents such as dexmedetomidine, ketamine, lidocaine, non-steroidal anti-inflammatory drugs, and regional analgesia. Opioid-based general anesthesia in this trial includes intraoperative remifentanil infusion. Participants will undergo elective urological surgery, including laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, or robotic cystectomy. The primary objective is to compare patient-reported quality of recovery between the opioid-free anesthesia group and the remifentanil-based anesthesia group using the Quality of Recovery-15 questionnaire. QoR-15 will be assessed before surgery and on postoperative day 7. Secondary objectives include total postoperative oxycodone dose administered via patient-controlled analgesia during the first 24 hours after surgery, postoperative pain intensity measured using the Numeric Rating Scale at 1, 2, 6, 12, and 24 hours after surgery, incidence of postoperative nausea and vomiting, change in serum creatinine from baseline to postoperative day 1, change in white blood cell count from baseline to postoperative day 1, and the ratio of demanded to delivered PCA boluses. Pre-specified subgroup analyses will compare outcomes according to surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed. Planned enrollment is approximately 600 patients, with 300 patients per treatment arm. The primary patient-reported recovery endpoint will be assessed on postoperative day 7, while analgesic, pain, and early postoperative safety outcomes will be assessed during the first 24 hours after surgery.

Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery. This randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. The PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups. SECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses. PRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots. Planned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.

Specialized immunological studies in the diagnostics of idiopathic infertility and recurrent miscarriages have limited applicability, as the role of the immune system in these conditions is not thoroughly understood. In ovulatory cycles, changes occur in the populations of uterine lymphocytes, which may influence the receptivity of the endometrium and the implantation of the embryo. Particularly notable are the changes in natural killer (NK) cells, which reach their peak during the luteal phase and regulate the invasion of the trophoblast. The dominant NK cells exhibit a CD56bright phenotype and differ in cytokine profiles from peripheral blood cells. Cyclical changes also affect macrophages and T lymphocytes; however, it is unclear whether their proportions differ in women with reduced fertility. There is a need to investigate how the composition of lymphocytes in blood influences the populations in the endometrium. The aim of this study is to analyze the correlation between peripheral and endometrial lymphocytes in women with idiopathic infertility and recurrent miscarriages, compared to fertile women.

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

This study will examine the work status of all adult patients admitted over a 6-month period to the University Hospital in Kraków, Poland, for treatment of urological diseases. All admitted patients will be surveyed about their job situation. Patients who are occupationally active and undergoing major oncological surgeries (such as radical cystectomy, prostatectomy, or nephrectomy) or procedures for urinary tract stones will also complete a quality-of-life questionnaire and be followed up by phone at 3 and 6 months. The goal is to learn how treatment affects patients' ability to return to work and their well-being, to help guide support and rehabilitation strategies.

This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer. Rectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established. This multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches. The results of this study may help guide treatment selection and improve care for people with rectal cancer.

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and reduces the need for opioids in the postoperative period.

The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOn-caRdiac surgery. The study aims to determine whether perioperative noradrenaline infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension.

The objective of the study is to prospectively assess the prevalence of post-traumatic stress disorder (PTSD) symptoms in a population of women who have experienced a diagnosis of ectopic pregnancy. The investigation into the prevalence of PTSD symptoms will aid in better identifying women who may benefit from early psychological intervention.

The objective of this questionnaire-based study is to prospectively assess the prevalence of post-traumatic stress disorder (PTSD) symptoms in a population of women who have experienced a spontaneous miscarriage during the first trimester of pregnancy. The investigation into the prevalence of PTSD symptoms will assist in better identifying women who may benefit from early psychological intervention.

Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.

1. The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy. 2. Unfavorably altered fibrin clot properties along with enhanced thrombin generation may lead to the development of complications during pregnancy such as TE and hypertensive disorders. 3. The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.

The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women. Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.

This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD. Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy. Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation. In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes. This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.

This study aims to evaluate how retroperitoneal lymph node dissection (RPLND), a surgical treatment for testicular cancer, may affect urinary and sexual functions in men. RPLND involves the removal of lymph nodes from the abdominal area and is sometimes necessary in patients who are not eligible for chemotherapy or who have residual disease after chemotherapy. While this surgery is known to carry a risk of affecting ejaculation, its potential impact on other areas such as urination or erection is not well understood. The study will prospectively follow adult men undergoing RPLND. It will assess changes in lower urinary tract symptoms, urine flow, ejaculation, erection, and overall quality of life before surgery and during follow-up visits up to 6 months after the operation. Patients will complete standardized questionnaires and undergo simple, non-invasive tests such as urine flow measurement. By identifying how RPLND may influence urinary and sexual health, this study seeks to improve understanding of the full range of effects of this treatment. The findings may help clinicians better inform patients before surgery and support improved post-operative care.

Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.

Modern anesthesiology, in search of alternatives to opioid-based pain management, is turning to low-opioid and non-opioid protocols. Replacing opioids with non-opioid analgesics, co-analgesics, and regional and local anesthesia techniques allows avoiding the adverse effects of opioids while maintaining satisfactory analgesia. This is of particular importance in bariatric surgery, where reducing the incidence of respiratory depression, sedation, opioid hyperalgesia, and postoperative nausea and vomiting is a priority. Standard non-opioid anesthesia (OFA) includes ketamine, lidocaine, and dexmedetomidine infusions, while regional techniques additionally reduce the need for analgesics. Despite the widespread use of these methods, there is no clear data on the superiority of any of them in bariatric procedures.

Bronchial asthma, as a chronic inflammatory disease of the respiratory tract, significantly reduces the quality of life of patients. Standard treatment includes pharmacotherapy, but a holistic approach, including manual therapies, can support pharmacological therapy, reducing the need for drugs. The aim of the research is to verify whether deep tissue massage (DTM) techniques applied to the chest significantly affect respiratory parameters in people with asthma. The study is the next stage of the study conducted on healthy people. After obtaining positive results in the study involving people not suffering from respiratory diseases, the next step is to examine people with, in this case, bronchial asthma. It is important to determine whether the use of this form of manual therapy can bring benefits in the context of improving respiratory functions, reducing respiratory muscle tension and relieving subjective symptoms associated with asthma, such as shortness of breath or limitations in everyday functioning. The hypothesis assumes that DTM techniques can have a bigger effect on the respiratory system than classic massage (CM). The study is a randomized controlled trial, where participants will be randomly assigned to one of two groups: the study group (subjected to DTM) or the control group (subjected to CM). Before and after the massage intervention, participants will undergo spirometry to assess the changes in respiratory parameters. The obtained data will then be analyzed for effects on respiratory parameters and differences between both groups.

The goal of this observational, longitudinal study is to identify risk and protective factors that buffer the effects of individual daily stress and adaptation to global crises on the quality of life and mental health conditions of young people entering adulthood (aged 18-29, fluent in Polish, and living in Poland). Moderators such as factors related to development, personality variables compatible with the domains according to ICD-11, psychological resilience, closeness in relationships with a partner/friends/parents, and the level of postformal thinking will also be considered. The main hypotheses it aims to consider are: H1: Poorer adaptation to individual and global crises is associated with higher levels of perceived stress, leading to worse indicators of mental health and quality of life. H2: A higher level of implementation of developmental tasks, including more fulfilled criteria of adulthood and a mature identity, mitigates the relationship between stress/ crisis adaptation and health and quality of life indicators. H3: Resilience and better relationships (closeness with a partner/ friends/ parents) buffer the negative effect of stress on health and quality of life. H4: A higher level of postformal thinking mitigates the relationship between stress/ crisis adaptation and health and quality of life indicators. H5: A higher intensity of psychopathological personality traits is a risk factor that amplifies the negative effect of stress on health and quality of life. Researchers will analyze measurements taken from the same group (a representative sample of Polish young adults) at two time points - now and in 12 months. The aim is to observe the extent to which the effects of current daily stressors and adaptation to the crisis, as well as the effects of potential moderators, are relatively stable.

Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Integral to PET scanners are detector systems that transform gamma photons into fluorescent photons, thereby gleaning insights into the energy, time, and spatial distribution of gamma photons emanating from positron-emitting radiopharmaceuticals. Conventional PET scanners, bear a significant financial burden primarily due to their reliance on LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. The exorbitant cost and limited availability of these crystal scintillators impede the widespread adoption of PET scanners. In a departure from conventional PET technology, the prototype J-PET scanner employed in this trial employs plastic scintillators, characterized by unique physical properties. This prototype is further equipped with bespoke software enabling three-photon imaging based on the annihilation of ortho-positronium (o-Ps) generated within diseased tissue. This study delves into the clinical applicability of PET scanners employing plastic scintillators, particularly investigating the feasibility of PET imaging using plastic scintillators where gamma quanta interact by mechanisms other than the photoelectric effect. Furthermore, this study endeavors to contemporaneously acquire and analyze data related to the lifetime of ortho-positronium (o-P) atoms emanating from routine radiopharmaceuticals. Additionally, it seeks to validate the utilization of a novel diagnostic indicator, termed the \"positron biomarker,\" through a prospective study, comparing its efficacy to conventional diagnostic PET scanning methodologies.

Colorectal cancer is the second most common malignancy in the countries of the European Union. Colonoscopy is the primary method for detecting and preventing the development of colorectal cancer is endoscopic examination. This study aims to evaluate the impact of artificial intelligence on the detection rate of polyps and early stages of colorectal cancer.

The goal of this observational study is to verify the association of previously underexplored psychological variables on postoperative pain experience and its progression over time in patients undergoing emergency and elective orthopedic surgeries, including both sexes (age range: 18-65). The main questions it aims to answer are: 1. Do psychological factors such as dysfunctional personality traits and emotional regulation explain the experience of pain after surgery and after six months? 2. Does the experience of the body mediate the relationship between dysfunctional personality traits and the experience of pain after surgery and after six months? 3. Does the experience of pain differ between patients who underwent emergency and elective orthopedic surgery (after surgery and after six months)? Researchers will compare the pain experience of patients undergoing emergency orthopedic surgery to those undergoing elective orthopedic surgery to see if there are significant differences in pain outcomes and recovery trajectories. Participants will: * complete psychological questionnairs to evaluate dysfunctional personality traits, emotional regulation, and body image; * report their subjective pain level and provide information on their coping strategies for managing pain and information about pain interference in everyday functioning; * engage in follow-up evaluation (6 months after the surgery) to assess the impact of pain on their daily activities and rehabilitation progress and complete some of the questionnaires again.