Clinical Research Directory

Physical Therapy After Endometriosis Excision

This is a randomized controlled pilot study comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Quality of life and endometriosis symptoms will be compared following the recovery period.

FOCUS Pre-Post Study

The Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. The purpose of this study is to assess the efficacy of the FOCUS guide in prompting discussion of the goal for surgery.

Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty

The study is designed to investigate the effect of a perioperative multicomponent rehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

The Effect of Ney Music on Patients Undergoing Lumbar Disc Surgery

This randomized controlled study aims to investigate the effects of ney music listening, a traditional Turkish wind instrument, on pain, anxiety, sleep quality, and vital signs in patients undergoing lumbar disc herniation surgery. Participants will be randomly assigned to intervention and control groups. The intervention group will receive a 15-minute ney music session at three different time points: preoperative (on the day of surgery), postoperative 3rd hour, and postoperative day 1. The control group will receive standard postoperative nursing care without music intervention. Data will be collected at the same time points in both groups using the Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Questionnaire, and vital signs. The study seeks to evaluate the non-pharmacological benefits of therapeutic music in postoperative recovery.

Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population

The current postoperative cataract surgery eye drop regimen used at Zuckerberg San Francisco General Hospital (ZSFG) is a significant burden for its patient population, contributing to high rates of non-adherence and the development of postoperative complications. The investigators propose to replace this complex regimen with a single administration of intraocular antibiotic and subconjunctival steroid at the time of surgery. This pilot study will obtain the preliminary data required to eventually fully evaluate this innovation in postoperative care in a safety-net population with respect to postoperative outcomes, patient compliance, and patient and caregiver satisfaction.

Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases

This is a multicenter, open-label, single-arm, prospective phase II clinical study. Eligible patients with lymph node-positive biliary tract cancer will undergo primary tumor resection with selective lymph node dissection. During surgery, the regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because of their location beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy. Following surgery, patients will receive postoperative radiotherapy to the primary tumor bed and involved/regional lymph node areas. For patients who undergo R0 or R1 resection, concurrent chemoradiotherapy with capecitabine or S-1 will be administered for 2 cycles, followed by 6 cycles of adjuvant chemotherapy. For patients who undergo R2 resection, concurrent radiotherapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, will be administered, followed by maintenance therapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, until disease progression or unacceptable toxicity.

The Role of Mandala Painting Before Surgery

Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. The universe of the study will consist of patients who will undergo elective surgery between June 2025 and June 2026 in the General Surgery Clinic of Istanbul Sultangazi Training and Research Hospital. Data will be collected using the Introductory Information Form, State Anxiety Inventory (STAI-S), Perceived Stress Scale (PSS), and Physiological Parameters Form (including blood pressure, pulse, respiration rate, and oxygen saturation). One day before surgery, patients who meet the inclusion criteria will be informed about the study and randomized into intervention and control groups using a random number table created with MS Excel software. Patients in the intervention group will perform a 20-minute mandala coloring activity in the preoperative waiting period. Before and after the application, participants' anxiety and stress levels will be evaluated with the STAI-S and PSS, and their physiological parameters will be recorded. Patients in the control group will receive standard preoperative care and will be evaluated at the same time points with the same tools, without any intervention. The study aims to provide evidence for the use of mandala coloring as a simple, low-cost, and effective nursing intervention to reduce preoperative anxiety and stress.

Music Interventions During Wide-Awake Hand Surgery

The purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.

The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY

Canadian hospitals continue to struggle with severe emergency department and hospital bed capacity shortages. Maximizing bed availability and minimizing emergency department and urgent-centre visits by providing patients with alternative options to care is an important part of the solution. Surgical patients with frailty are at high risk of requiring subsequent acute-hospital care. The VICTORY trial will answer an important question that will inform how to improve care for surgical patients with frailty by determining the effect of virtual care with CloudDX technology compared to standard care to see if it can result in an increase in the number of days alive and at home that older people with frailty experience after planned surgery.

Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer

Health establishments encourage the development of specific care pathways for the elderly by supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a clear reduction in mortality and the number of re-hospitalizations in patients 6 months after their care. The multidisciplinary approach of global management of the patient in the perioperative period aims to reduce surgical stress as well as the rapid restoration of previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved rehabilitation after colorectal surgery, care programs are not specific to the geriatric population and geriatric assessment criteria to describe the functional status of patients are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment following colorectal surgery, on the evolution of several clinical parameters such as: functional status, morbidity mortality, quality of life, and lifestyle. The study investigators hypothesize that management in the GPOU for colorectal cancer surgery in patients aged 70 and over will improve functional status at 3 months, in comparison with traditional management. The proposed intervention should also lead to an improvement in patient satisfaction with care, complications and re-hospitalizations, nutritional status, lifestyle and patient survival.

Premedication Gastric Ultrasound

The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.

Prevena Spine for Use in Spine Surgery

A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery

The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.

Prospective Longitudinal Study of Sleep, Brain Activity, and Plasma Analyses in Patients Undergoing Epilepsy Surgery

The goal of this observational study is to understand how sleep and brain activity change after epilepsy surgery in adults with drug-resistant epilepsy. Drug-resistant epilepsy means that seizures continue despite treatment with appropriate medications. The study will investigate whether changes in sleep and brain activity are related to seizure control, sleep quality, and quality of life after surgery. The main questions it aims to answer are: * How do sleep patterns and brain activity change after epilepsy surgery? * How are changes in sleep and brain activity related to seizure control and quality of life? * Do sleep patterns after surgery become more like those of healthy adults? * How are changes in blood proteins related to sleep, brain activity, and seizure control? Researchers will follow 30 adults undergoing epilepsy surgery. Their sleep will be compared with that of 10 healthy adults of similar age and sex. Healthy participants will complete the study assessments once. Participants undergoing epilepsy surgery will complete the assessments before surgery and approximately 2 and 6 months after surgery. At each assessment, participants will: * Wear a small device (actigraph) on their wrist for about 2 weeks to measure sleep and activity and keep a sleep diary. * Spend 2 consecutive nights at a patient hotel while their sleep and brain activity are recorded using polysomnography (PSG), a test that measures sleep, breathing, and brain activity. * Answer questionnaires about sleep quality, insomnia, mood, and quality of life. * Provide blood samples for research. Researchers will also collect information about seizure frequency, medications, and medical history. The sleep recordings will be used to study several aspects of sleep, including: * Sleep architecture: how much time participants spend in different stages of sleep and how often their sleep is interrupted. * Sleep spindles and slow oscillations: patterns of brain activity during sleep that are involved in how the brain processes and organizes information. * Cyclic alternating pattern (CAP): a measure of brief changes in brain activity during sleep that can provide information about sleep stability. * Epileptiform activity: abnormal electrical activity in the brain that may be associated with epilepsy and can occur during sleep. Researchers will also analyze proteins in blood samples to explore whether biological changes are related to sleep and seizure outcomes. Epilepsy surgery and other medical treatments will be decided by the participants' treating healthcare teams, independently of this study. The study will observe changes before and after surgery without assigning participants to a treatment.

Effects of Aromatic Solution Applied After Surgery

Today, surgical applications are used to solve many health problems. In order for the surgical intervention to take place, anesthesia applications are often required. Complications such as sore throat, thirst and nausea and vomiting may occur as a result of trauma, local irritation and inflammation of the airway mucosa during anesthesia and tracheal intubation. These complications are in the postoperative period; It may cause delayed oral fluid intake, prolonged dehydration, oral odour, and increased risk of aspiration, hematoma and wound dehiscence due to retching and vomiting, all of which may lead to delayed discharge and increased cost. Aromatherapy, one of the non-pharmacological applications, is frequently applied in reducing postoperative complications and its effectiveness is stated. In this study, the aromatic solution applied after the surgery; It was planned to examine the effect on sore throat, thirst, nausea-vomiting. In addition, the multimodal synergistic effect of lavender oil and ginger oil used in the aromatic solution to be prepared will be utilized. As a result of this study, the effectiveness of the aromatic solution application to be applied to the patients in the postoperative period and the benefits and benefits of the patient's recovery process will be determined. Thus, effective application can be made for the entire postoperative period. It is thought that this study to be conducted will be a guide for future studies on the patient group.

Handheld US Device to Verify Vascular Cannulation

This a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients using the rapid atrial swirl sign (RASS) technique. As emerging technologies have made hand-held ultrasound devices more versatile, portable, and cheaper, it will be important to prove if they can be as accurate as traditional ultrasound devices for their intended focused point-of-care functions. If the handheld device is deemed efficacious, it will allow the use of a portable hand-held device rather than the more difficult to transport devices (Sonosite).

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?

Hemoglobin Levels for Blood Transfusions During and After Surgery

The goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. Participants in this study are adults undergoing surgery with a risk of significant blood loss. The main question it aims to answer is: * Is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible? Participants will: * Receive blood transfusions during surgery based on a higher (less than 90 g/L) or a lower (less than 70 g/L) hemoglobin value. * Complete questionnaires at 30 and 90 days after surgery.

Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy

Laparoscopic and minimally-invasive robotic access has transformed the delivery of urological surgery. While associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function, these techniques have also been associated with morbidity such as reduced renal blood flow and post-operative renal dysfunction. The mechanisms leading to these renal effects complex are multifactorial, and have not been fully elucidated. However they are likely to include direct effects from raised intra-abdominal pressure, and indirect effects secondary to carbon dioxide absorption, neuroendocrine factors and tissue damage from oxidative stress. It is well documented that pneumoperitoneum places profound stress on the cardiovascular, respiratory and gastrointestinal systems; it also places strain on the renal system. During robotic surgery, continuous pneumoperitoneum and continuous rising of intra-abdominal pressure causes transient oliguria. Moreover, kidney function, estimated by the GFR, deteriorates during elevated intra abdominal pressure (IAP), and most of the studies identified decrease in renal blood flow (RBF) and renal cortical perfusion. Studies conducted to assess the contribution of the nitric oxide (NO) system to the renal hemodynamic/function alterations during pneumoperitoneum, concluded that these adverse effects are probably related to interference with the NO system, and could be partially ameliorated by pretreatment with nitroglycerine. Mannitol is an osmotic diuretic and a renal vasodilator that promotes tubular flow, prevents intratubular cast formation, decreases postischemic cellular swelling, and might serve as a free radical scavenger. Mannitol has traditionally been administered before renal surgeries to minimize perioperative renal dysfunction according to preclinical animal studies and clinical experience with renal transplantation. However, high-level clinical data in support of this belief are not available. The aim of this study is to characterize the effects of increased intra-abdominal pressure on renal perfusion and function in cases undergoing robotic lower tract urologic surgeries, and to assess the contribution of either mannitol or nitroglycerin infusion to the renal hemodynamic/function alterations during pneumoperitoneum.

Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients

There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC). Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices. Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability. The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.

Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

Gastric US in ICU Patient

This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

The goal of this stepped-wedge randomized controlled trial is to investigate whether implementation of a best practice program for preoperative optimisation (prehabilitation program) with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors in patients with (suspected) pancreatic cancer will improve outcome. The main questions it will aim to answer are: 1. Does a prehabilitation program improve the time to functional recovery after pancreatic surgery? 2. Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?

EMG ss AMG In Robotic/Laparoscopic Surgery

The purpose of this study is to compare the mean cumulative weight-based/time-corrected rocuronium dose administered in patients undergoing robotic- or laparoscopic- assisted surgery using either acceleromyography or electromyography.