Clinical Research Directory

Pre-habilitation Within ERAS Protocol for Gynecologic Oncology Surgery: The Pre_ERAS Study

ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner. A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.

A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™

Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (SSIs) following implant-based breast reconstruction in female patients, aged 18 and older. It will also assess the safety and overall surgical outcomes when using Xperience™ compared to povidone-iodine. Main Questions the Study Aims to Answer: * Does the use of Xperience™ decrease the incidence of surgical site infections compared to povidone-iodine? * What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience™ and those treated with povidone-iodine? * Are there fewer post-surgical complications with Xperience™ compared to povidone-iodine? Study Design: Participants in this study will be randomly assigned to receive either Xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. Only the research team will know which irrgiation is given- the participant will not know. Participant Will: * Undergo the surgical procedure using one of the two irrigation solutions. * Receive regular post-operative check-ups to monitor for signs of infection and other complications. * Have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.

Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study

The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously. The main questions it aims to answer are: 1. What is the perceived need for breast implants after weight loss surgery, described as the proportion who have breast implants, and what characteristics, in terms of demographics and surgical details, do the operated women have? 2. In women who have breast enlargement or breast enlargement combined with a lift, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example skin incision and choice of implant (for example texture, shape, size)? 3. In women who have delayed breast reconstruction after breast cancer, that is have had their breast/s reconstructed in a separate operation, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 4. In women who have immediate breast reconstruction after breast cancer?, that is have a breast reconstruction at the same time as the mastectomy, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 5. In women who have risk reducing mastectomies, are there any differences between he women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 6. Are there any identifiable risk factors for complications after breast reconstructive surgery, specific to the women who have had weight loss surgery and other women? Researchers will compare the patients to women who have the same type of reconstructive breast surgery but have not had bariatric surgery previously. The study will use prospectively collected data from seven registers: The Scandinavian Obesity Surgery Register (SOReg), The Swedish Breast Implant Register (BRIMP), the Swedish National Quality Register for Breast Cancer (NKBC), the Swedish National Diabetes Register (NDR), Statistics Sweden (SCB), the Swedish inpatient register, and the Swedish National Prescribed Drug Register.

A Real-World Registry of Chronic Wounds and Ulcers

WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.

Telehealth Interventions for Cardiac Surgery

The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are: 1. Can telehealth improve quality of life prior to surgery 2. Can telehealth prevent serious deterioration requiring hospital or primary care attendance Participants awaiting heart surgery will be randomly allocated to either telehealth remote monitoring of symptoms, blood pressure, heart rate, oxygen levels and activity levels or they will be allocated to usual care which is unmonitored on the waiting list for surgery. Researchers will compare telehealth to usual care to see if it improves quality of life or prevents deteriorations on the waiting list.

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.

Surgical Approach to Uterine Septum

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on: The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery

The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass. All measurements and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.

Prehabilitation for Ovarian Cancer Patients

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery

Study objective: This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots. Eligible patients: Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery. Study intervention: Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

Gastrointestinal Dysfunction in Aortic Surgery Patients

The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary \[calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)\] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.

Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia

The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is: Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery