Clinical trials

This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.

Anterior cruciate ligament (ACL) reconstruction is commonly associated with moderate to severe postoperative pain, particularly during the early postoperative period and rehabilitation. Effective postoperative analgesia is important to facilitate early mobilization, improve patient comfort, and reduce opioid consumption and opioid-related adverse effects. Adductor canal block (ACB) is commonly used as part of multimodal analgesia for knee surgery because it provides analgesia while largely preserving quadriceps motor function. However, ACB primarily targets the anteromedial aspect of the knee and may provide limited analgesia for pain arising from the posterior and posterolateral knee. The biceps femoris short head (BiFeS) block is a motor-sparing fascial plane block targeting sensory contributions to the posterolateral knee region. Combining BiFeS block with ACB may therefore provide more comprehensive analgesia than ACB alone. This randomized study aims to compare the postoperative analgesic efficacy of adductor canal block alone with adductor canal block combined with BiFeS block in patients undergoing anterior cruciate ligament reconstruction surgery.

Radiographic axial spondyloarthritis (r-axSpA) causes progressive structural damage of the spine, conventionally quantified on lateral cervical and lumbar radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Repeated radiography entails cumulative radiation exposure, substantial inter-reader variability and low sensitivity in early disease. DIERS Formetric 4D surface topography provides radiation-free three-dimensional modelling of the spine and pelvis. The association between sagittal balance and structural damage has been demonstrated with a radiation-based system (EOS), but whether a radiation-free topographic method reflects the same association has not been investigated. This single-centre, cross-sectional observational study will enrol 53 adults with r-axSpA fulfilling the ASAS criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, BASMI, BASDAI, BASFI and ASDAS-CRP are obtained. mSASSS is scored by two independent readers, blinded to clinical and topographic data, on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are performed for the study. The primary analysis is the correlation between total mSASSS and the DIERS fleche cervicale (cervical sagittal anterior displacement).

In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

This single-center, single-blind, randomized, sham-controlled clinical trial will include 60 patients aged \>45 years who are within 3 months of a first-ever middle cerebral artery ischemic stroke. Participants will be randomized into four groups: coupled TBS (contralesional cTBS followed by ipsilesional iTBS), cTBS plus sham iTBS, sham cTBS plus iTBS, or sham TBS. TBS will be delivered over the primary motor cortex for 10 sessions over 2 weeks. Stimulation intensity will be set at 80% of the resting motor threshold determined using EMG-guided motor evoked potentials. Each cTBS and iTBS application will consist of 600 pulses. All participants will additionally receive standardized conventional rehabilitation for at least 4 weeks. The primary outcome will be upper-extremity motor recovery assessed using the motor domain of the Fugl-Meyer Assessment. Secondary outcomes will include lower-extremity motor recovery, spasticity, sensory function, cortical excitability, functional ambulation, activities of daily living, and stroke-specific quality of life. Assessments will be performed at baseline, after the 2-week intervention, and at 1-month post-treatment follow-up.

This prospective observational cohort study will evaluate whether the Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) can predict short-term clinical outcomes in adults aged 65 years or older with isolated blunt thoracic trauma and more than three rib fractures. Participants will be enrolled in the Emergency Department of Ankara Etlik City Hospital. No experimental drug, device, or additional invasive procedure will be used. Routine clinical, laboratory, anthropometric, imaging, and follow-up data will be recorded. The study plans to include 294 participants. The primary outcome is a composite short-term poor clinical outcome, including in-hospital mortality, intensive care unit admission, invasive or non-invasive mechanical ventilation, pneumonia, atelectasis, tube thoracostomy, or hospital stay of 7 days or longer. The prognostic performances of GNRI and PNI will be compared. Secondary outcomes include the individual components of the composite outcome, new pneumothorax or hemothorax, hospital and intensive care unit length of stay, 30-day emergency department revisit, and 30-day mortality.

This prospective observational cohort study will evaluate whether the perfusion index measured at emergency department admission is associated with the severity of diabetic ketoacidosis in adults. The study will include 140 patients aged 18 years or older who are diagnosed with diabetic ketoacidosis in the emergency department. The perfusion index will be measured using pulse oximetry. Serum lactate measured as part of routine clinical care will also be recorded, and the lactate-to-perfusion index ratio will be calculated. The ability of the perfusion index, serum lactate, and the lactate-to-perfusion index ratio to predict diabetic ketoacidosis severity will be compared. Their associations with time to diabetic ketoacidosis resolution, intensive care unit admission, hospital and intensive care unit length of stay, mechanical ventilation, vasopressor use, and in-hospital mortality will also be evaluated. No treatment will be assigned by the investigators, and all patients will receive routine clinical care.

"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine. Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."

Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort. This randomized controlled trial aims to evaluate the efficacy of adding a recto-intercostal fascial plane block (RIFPB) to an external oblique intercostal plane block (EOIPB). Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to receive either an EOIPB alone or a combination of EOIPB and RIFPB. The primary objective is to determine if the combined block approach provides superior postoperative analgesia, evaluated by compared to the EOIPB alone.

This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy. Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs. The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure \< 65 mmHg or a decrease in systolic blood pressure \> 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.

Shoulder surgeries are among the most frequently performed orthopedic interventions and are often associated with moderate to severe postoperative pain. In these procedures, effective pain management is crucial for early rehabilitation and patient comfort. Peripheral nerve blockade is widely used for postoperative analgesia in shoulder surgery. While the interscalene brachial plexus block is considered the gold standard for pain control, it is frequently associated with unintended phrenic nerve blockade, leading to hemidiaphragmatic paresis. To minimize respiratory complications while maintaining effective analgesia, alternative diaphragm-sparing regional anesthesia techniques, such as the combination of suprascapular and axillary nerve blocks, have been introduced. The aim of this study is to compare the analgesic efficacy and respiratory functions preservation of the ultrasound-guided anterior approach suprascapular combined with axillary nerve block versus interscalene block in patients undergoing shoulder surgery

The aim of this prospective, randomized controlled trial is to compare the analgesic efficacy of transverse versus longitudinal ultrasound probe orientations during Serratus Anterior Plane (SAP) block in patients undergoing breast surgery. The study hypothesizes that the longitudinal approach (probe parallel to the ribs) may provide better craniocaudal spread of the local anesthetic, thereby resulting in lower postoperative Visual Analog Scale (VAS) scores and reduced opioid consumption compared to the standard transverse approach.

Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly impair daily activities and quality of life. Conservative treatments, including physical therapy modalities and injections, are considered first-line management. High-Intensity Laser Therapy (HILT) is a non-invasive modality with greater tissue penetration compared to low-level laser therapy and has shown promising results in musculoskeletal disorders; however, evidence in GTPS is limited. This study aims to evaluate the efficacy of HILT compared with a sham intervention in patients with GTPS, focusing on pain intensity, functional status, and quality of life.

This randomized controlled trial aims to evaluate and compare the effectiveness of combined contrast therapy with intermittent compression and whirlpool therapy in patients with post-traumatic CRPS-I of the hand and wrist, using objective outcome measures of pain, edema, and functional status.

This study aims to compare the clinical outcomes of 45 V and 60 V pulsed radiofrequency (PRF) applied to the cervical dorsal root ganglion (DRG) in patients with cervical radicular pain. Treatment efficacy will be evaluated using the Numerical Rating Scale (NRS) for pain intensity and the Neck Disability Index (NDI) for functional disability. Procedure-related adverse events will also be compared to assess the safety of both voltage settings.

This prospective, randomized controlled trial aims to compare the clinical outcomes of laparoscopic appendectomy performed under two standard pneumoperitoneum pressures (10 mmHg and 15 mmHg). The primary objective is to evaluate postoperative pain, while secondary outcomes include operative time, conversion rate, time to first flatus and bowel movement, length of hospital stay, postoperative ileus, and intra-abdominal abscess formation. The study will determine whether lower-pressure pneumoperitoneum provides comparable surgical conditions while improving postoperative recovery.

This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI). Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy. The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration. A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.

This prospective observational cohort study aims to evaluate the association between menstrual phase (determined by postoperative serum progesterone levels), intraoperative anesthetic consumption, and the incidence and severity of postoperative nausea and vomiting (PONV) in female patients undergoing cholecystectomy. Intraoperative anesthetic requirements will be recorded, and postoperative nausea and vomiting will be assessed using standardized scoring systems.

Abstract Objective: The aim of this study is to compare two different ways of adjusting the air-filled cushion (cuff) of the breathing tube used during general anesthesia in children undergoing laparoscopic appendectomy (closed surgery for appendicitis). The goal is to see if maintaining the pressure in this cushion within a safe, specific range (15-18 mmHg) helps prevent or reduce sore throat, hoarseness, and discomfort, which are common postoperative complications in children. Study Design: This is a prospective, randomized, controlled study. Sixty children aged 6 to 18 years scheduled for laparoscopic appendectomy will be included. Participants will be randomly assigned to two equal groups: Group A (Control Group): Breathing tube cuff pressure is adjusted using the standard "feeling" (finger palpation) method common in routine practice. Group B (Intervention Group): Breathing tube cuff pressure is measured throughout the surgery using a medical pressure sensor (manometer) and maintained within a safe range (15-18 mmHg). Research Questions: Does actively monitoring airway pressure reduce the number of children experiencing postoperative sore throat? Does this method reduce the severity of sore throat, cough, hoarseness, or other respiratory discomfort compared to the standard method? What will happen? During surgery, respiratory and heart rate measurements will be recorded every 15 minutes for all participants. After surgery, researchers will visit participants (and their parents) at 2, 6, and 24 hours postoperatively to assess the presence of sore throat, discomfort, or hoarseness. No additional medications or invasive procedures will be used for this study; only how we manage airway pressure will be compared.

The aim of this study is to evaluate the effect of written or visual information provided outside of routine postpartum follow-up on pelvic floor knowledge and pelvic floor function in women during the postpartum period.

The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.

The primary aim of this study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication. The secondary aim of the study is to evaluate its effectiveness on upper extremity function, quality of life, sleep, and fatigue.

The costoclavicular approach of the infraclavicular brachial plexus block is widely used for upper extremity surgeries due to its reliable anatomy and high success rates. Patient positioning, particularly the degree of arm abduction, may influence the spread of local anesthetic and the characteristics of the block. However, the optimal arm abduction angle during this procedure remains unclear. This prospective randomized controlled trial aims to investigate the effect of two different arm abduction angles (90° and 120°) on block onset time and block success in patients undergoing hand, wrist, and forearm surgery under ultrasound-guided costoclavicular brachial plexus block. Patients will be randomly assigned to one of two groups according to the degree of arm abduction. The primary outcome is block onset time. Secondary outcomes include block success, sensory and motor block characteristics, perfusion index changes, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia, postoperative neurological evaluation at 4 and 24 hours, complications, and patient satisfaction. The findings of this study are expected to provide evidence on optimal patient positioning to improve the effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.

This prospective randomized trial aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing colorectal surgery. Patients will be randomly assigned to receive either mean arterial pressure-guided or cardiac index-guided intraoperative hemodynamic management. Colorectal surgery is a major abdominal procedure associated with prolonged operative times, significant fluid shifts, blood loss, and hemodynamic instability. These factors can contribute to impaired renal perfusion and subsequent postoperative renal dysfunction. Although mean arterial pressure is widely used to guide intraoperative hemodynamic management, blood pressure alone may not adequately reflect systemic blood flow or regional tissue perfusion. Cardiac index-guided management may provide a more direct assessment of global circulatory adequacy. The primary outcome of the study is the change in serum creatinine levels from the preoperative baseline to 72 hours postoperatively. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, intensive care unit (ICU) and hospital length of stay, and 30-day mortality.

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide. Despite being classified as a minor surgical intervention, moderate to severe postoperative pain is reported in approximately 60% of patients. In a subset of these patients, acute postoperative pain may persist and evolve into chronic post-surgical inguinal pain, significantly affecting quality of life. In recent years, beyond the use of systemic intravenous analgesics, ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia protocols with the aim of reducing postoperative opioid consumption and improving pain control. However, the current literature does not provide definitive evidence regarding the superiority of one block technique over another in this surgical population. The primary objective of the present study is to compare the analgesic efficacy of the Quadro-iliac Plane Block (QIPB) and the transversus abdominis plane block (TAPB) in patients undergoing inguinal hernia repair.