Robotic Surgery

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-treatment.

Researchers are evaluating pain control methods following robotic lung surgery. This prospective randomized single-blinded clinical trial compares two approaches: wound infiltration and intercostal nerve block using either liposomal bupivacaine or a combination of bupivacaine/epinephrine plus dexamethasone. Liposomal bupivacaine is a newer local anesthetic that has not yet been compared to the established bupivacaine/epinephrine plus dexamethasone combination in this surgical context. Participants will be randomly assigned to one of two groups. One group will receive an intercostal nerve block and wound infiltration with 266 mg of liposomal bupivacaine combined with 24 ml of 0.5% bupivacaine. The other group will receive intercostal nerve block and wound infiltration with 42 ml of 0.5% bupivacaine/epinephrine plus 8 mg dexamethasone during their robotic lung resection surgery. During the study, participants' pain levels will be assessed using the Visual Analogue Scale 24 hours after surgery. Researchers will monitor and compare pain control effectiveness between the two treatments. The trial is led by The Cooper Health System and includes adults aged 18 to 90 undergoing robotic wedge resection or lobectomy for lung masses. The study's design includes randomized allocation and double masking to ensure unbiased results.

Robotic-assisted laparoscopic surgery is increasingly used, especially for older and more fragile patients who may not tolerate major open surgery. This research focuses on the challenges to heart function during robotic surgery involving a steep 30-degree head-down tilt (Trendelenburg position), which can increase the heart's workload. The study compares patients with normal heart function to those with systolic heart failure under these conditions to understand circulatory effects better. Participants undergo preoperative echocardiography to classify heart function as normal or decreased (ejection fraction 45% or lower). During surgery, heart performance is monitored using an esophageal doppler device, while brain oxygen levels are measured by optical spectrophotometry. Measurements are taken before anesthesia, during Trendelenburg positioning, at the start of the pneumoperitoneum (carbon dioxide insufflation), and after returning to a flat position. Throughout the study, standard anesthesia parameters and various cardiac output measures are recorded to analyze heart workload changes. The main outcome is the change in stroke volume during Trendelenburg positioning and pneumoperitoneum within 15 minutes. Secondary outcomes include changes in systemic vascular resistance, pulse pressure variation, peak velocity, stroke volume variation, flow time corrected, and regional brain oxygen saturation. This observational study helps identify which patients may be at risk of heart complications during robotic surgery and informs safer surgical decisions.

Gynecologic cancers are increasing worldwide, making it crucial to improve care around the time of surgery. This research compares two common tools used to predict risks during onco-gynecologic surgeries: the Charlson Comorbidity Index (CCI), which focuses on patients' other medical conditions, and the POSSUM score, which includes both physical health and surgery details. The study aims to see how well these tools predict complications, hospital stay length, and death within 30 days after surgery to help doctors better manage risks. The study observes patients undergoing planned onco-gynecologic surgeries for cancers such as ovarian, cervical, uterine, and vulvar cancer. Researchers will assess each patient using the CCI and POSSUM scores based on their medical history and surgery factors. These scores will then be compared to actual outcomes like surgical complications and mortality. This approach does not involve experimental treatments but uses these risk tools to evaluate their accuracy and usefulness. Participants will be monitored from the day of surgery until hospital discharge, up to 30 days, to track complications, blood loss, blood pressure issues, ICU admissions, reoperations, heart or kidney problems, lung complications, and survival. The study collects detailed clinical data and anesthesia records to compare the two scoring methods. This information aims to improve teamwork among doctors and nurses and enhance patient safety during complex gynecologic cancer surgeries.

Researchers are evaluating two types of lymphadenectomy—transperitoneal and transvaginal paracervical—during the lymphadenectomy phase of endometrial cancer staging surgery using V-NOTES, a new and advanced surgical approach. This randomized, prospective, controlled study aims to optimize the V-NOTES technique for staging early-stage endometrial cancer by comparing surgical and functional outcomes between the two methods. Patients diagnosed with endometrial cancer through biopsy and imaging are enrolled and randomly assigned to one of the two lymphadenectomy groups. In the transvaginal paracervical lymphadenectomy group, patients undergo V-NOTES surgery beginning with methylene blue dye injection around the cervix, followed by sentinel lymph node mapping, hysterectomy, and removal of ovaries and fallopian tubes. The transperitoneal lymphadenectomy group receives V-NOTES surgery starting with methylene blue injection, anterior and posterior colpotomies, placement of the V-NOTES device, hysterectomy, and then lymph node removal through peritoneal dissection. Both groups receive similar surgical procedures with differences in lymphadenectomy approach. Participants will be assessed during surgery and hospitalization for operation duration, bleeding, lymph node removal, and complications. Follow-up evaluations include postoperative pain and sexual function at 3 and 6 months. Tumor pathology and other surgical outcomes are monitored up to the study completion. The study duration covers recruitment from March to December 2025 with ongoing follow-up through early 2026. Data will be collected on surgical safety, effectiveness of lymph node mapping, and recovery measures.

Researchers are evaluating the recovery and safety of patients undergoing robotic assisted hysterectomy, comparing those who go home the same day (day-care) to those who stay at least one night in the hospital. The study includes patients with both benign conditions and endometrial cancer. Quality of life after surgery will be measured using the EQ-5D-5L questionnaire at multiple time points to assess recovery speed and patient satisfaction. Participants are randomly assigned to one of two groups: the experimental group goes home the same day as surgery, while the control group stays overnight in the hospital. The study is conducted across three hospitals, with benign cases treated at two sites and endometrial cancer cases at a third. An additional questionnaire about satisfaction with hospital stay length will be given 30 days after surgery. During the study, patients will complete quality of life questionnaires before surgery and then at 3, 7, and 30 days after surgery. Researchers will also monitor surgical complications, readmissions, reoperations, and sick leave within 30 to 60 days post-surgery. Socioeconomic costs will be evaluated, and the total participation period spans from surgery to 60 days after. Safety and patient recovery outcomes are carefully recorded throughout.

Researchers are evaluating the effects and safety of dexamethasone palmitate compared to traditional dexamethasone for preventing postoperative nausea and vomiting (PONV) after open surgery. Although dexamethasone is commonly used to reduce PONV, some patients still experience symptoms within 24 hours after surgery. Dexamethasone palmitate has a longer-lasting anti-inflammatory effect and fewer side effects, making it a promising option for managing PONV. Participants will be randomly assigned to one of two groups. One group will receive an intravenous injection of dexamethasone palmitate 8 mg (containing 5 mg dexamethasone) after anesthesia induction and before surgical incision. The other group will receive an intravenous injection of dexamethasone 5 mg at the same time. The trial compares these treatments in patients undergoing elective open surgeries such as spinal, chest, or abdominal surgery. During the study, researchers will monitor participants for the incidence and severity of PONV at multiple time points within 72 hours after surgery. They will also track the use of rescue antiemetic medications, participant satisfaction with PONV management, pain levels using the VAS scale, quality of postoperative recovery, length of hospital stay, and safety outcomes up to one month after surgery. The main outcome is the occurrence of PONV within the first 24 hours postoperatively. Participation lasts through the surgery and follow-up periods as described.

Intracerebral hemorrhage (ICH), a type of stroke causing significant death and disability, is being studied to see if early minimally invasive endoscopy-guided surgery improves patient outcomes compared to standard medical care. This trial focuses on adults with spontaneous supratentorial ICH, aiming to begin surgery within 8 hours of symptom onset. The study is a multicenter, randomized clinical trial led by Radboud University Medical Center, investigating both functional recovery and biological changes after treatment. Participants are randomly assigned to receive either minimally invasive endoscopy-guided surgery plus standard medical management or standard medical management alone. The surgical procedure uses neuronavigation-integrated devices approved for this purpose. Surgery must start within 8 hours of symptoms, and the trial includes detailed monitoring of brain imaging and immune profiles in a subgroup. The standard care group receives blood pressure management, stroke unit admission, and supportive care. Participants will be followed for up to one year with assessments at 6 days, 90 days, 180 days, and 365 days including functional scales like the modified Rankin Scale, stroke severity scores, quality of life questionnaires, and safety monitoring for complications or death. Imaging studies at baseline, 24 hours, and day 6 assess clot and edema changes. The trial also evaluates cost-effectiveness of the surgical approach. Overall participation spans up to one year with multiple clinical and imaging evaluations.

Researchers are studying the effects of two types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and robotic sleeve gastrectomy (RSG), in adults eligible for sleeve gastrectomy under NIH guidelines. This interventional trial aims to compare early postoperative pain between the two surgical approaches, as well as surgeon comfort and patient quality of life. Additional outcomes include 30-day perioperative results, complications, serious adverse events, resolution of obesity-related conditions, and weight loss one year after surgery. The study randomly assigns participants to receive either standard laparoscopic sleeve gastrectomy or robotic-assisted sleeve gastrectomy. Both procedures involve removing part of the stomach to promote weight loss, but robotic surgery offers potential benefits such as better 3D visualization and improved surgeon ergonomics. All surgeries occur at a single center, and each participant undergoes only one type of surgery during the trial. Participants will be monitored closely after surgery to assess pain levels using morphine dose consumption and pain scores at 1, 7, and 30 days post-operation. Quality of life will also be evaluated at 30 days, and surgeon ergonomics will be assessed during surgery. Researchers will track complications and medical improvements up to one year, including weight loss expressed as percent of excess weight lost. The trial will last until April 2027, with various follow-up assessments scheduled throughout the year.