Laparoscopic 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 the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories in hepatopancreaticobiliary (HPB) and foregut surgeries. These operations include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study aims to collect data on the system's use in these complex surgical procedures at a single center. The study is divided into four stages based on the participant's diagnosis and the type of operation. Each participant will undergo one operation using the da Vinci SP-assisted Single Port Robot. Stage One involves cholecystectomy and hiatal hernia repair with fundoplication. Stage Two includes gastrectomy and distal pancreatectomy. Stage Three covers pancreaticoduodenectomy and esophagectomy. Stage Four involves hepatectomy. The da Vinci SP system uses a minimally invasive single-port approach with a surgeon console, vision cart, patient cart, camera, instruments, and accessories. During the study, participants will be monitored for completion of surgery using the planned robotic system, intraoperative and postoperative adverse events, positive resection margins, and lymph node yield over periods up to 24 months. Additional assessments include physical status, comorbidity scores, operative time, blood loss, complications, mortality, discharge date, survival, disease recurrence, and readmission rates. Follow-up extends annually through five years to evaluate long-term outcomes and safety. Participants will be observed closely to collect comprehensive surgical and recovery data.

Researchers are evaluating the effects of heated humidified high flow nasal cannula (HFNC) oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications (PPC). The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy. Participants are randomly assigned to one of two groups: the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37°C and a maximum flow of 70 liters per minute. During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.

This research aims to evaluate the performance and safety of the HARMONIC 700 Shears device when used according to its instructions in both pediatric and adult surgical procedures. The study includes pediatric general surgeries and adult general, gynecological, urological, and thoracic surgeries. It is designed as a prospective, single-arm, multi-center observational study to collect data in a real-world post-market setting. During the study, surgeons will use the HARMONIC 700 Shears device following their standard surgical methods and the device's instructions for use. The study will capture data from these procedures without additional interventions beyond necessary clinical care. Participants include children under 18 undergoing non-emergency surgeries and adults undergoing elective surgeries, with at least one vessel transection performed using the device. Participants will be monitored from the time of surgery through hospital discharge and again about 28 days afterwards. Researchers will assess the success of vessel sealing during surgery and track any device-related adverse events for up to approximately one year and seven months. The main outcomes include the number of vessel transections achieving a certain level of hemostasis and safety events related to the device.

Researchers are evaluating how artificial intelligence (AI) can improve safety during laparoscopic cholecystectomy, a minimally invasive gallbladder removal surgery. This study compares surgeries guided by AI tools to standard procedures without AI, focusing on whether AI helps surgeons achieve the Critical View of Safety, a key step to reduce the risk of serious complications. This randomized controlled trial includes surgeons or fellows performing the procedures and aims to collect feedback on AI use and surgical safety outcomes. The study involves 10 surgeons or fellows and 50 adult patients undergoing laparoscopic cholecystectomy at two hospital sites. Participants are randomly assigned to either the control group using standard surgical care or the intervention group where surgeons receive real-time guidance from two AI models displayed on a monitor during surgery. The AI models highlight safe and unsafe dissection zones and provide text feedback on achieving surgical safety milestones. Surgeons can toggle or turn off AI guidance as needed. Procedures are recorded for post-operative review by expert surgeons. During the study, researchers will collect internal laparoscopic recordings, surgeon feedback immediately after surgery, observational notes during procedures, and review patient charts up to 30 days post-operation. The primary outcome is the rate at which surgeons achieve the Critical View of Safety, monitored for up to one year after surgery. Secondary outcomes include the safety of dissections, surgeon experience with AI, and short-term patient outcomes. The study lasts from surgery through one year of follow-up for outcome analysis.

Researchers are evaluating the effectiveness of Serratus Posterior Superior Intercostal Plane (SPSIP) block compared to Intercostal Nerve (ICN) block for managing pain after video-assisted thoracoscopic surgery (VATS). This study aims to compare these two methods in terms of controlling postoperative pain, reducing opioid use, minimizing respiratory complications after surgery, and improving patient satisfaction measured by a 5-point Likert scale. In this prospective observational study, patients receive both the SPSIP block and the ICN block for pain relief after surgery. The SPSIP block is done by an anesthesiologist using ultrasound guidance right after skin closure and before the breathing tube is removed. The ICN block is performed by the surgeon under direct vision just before skin closure. During surgery, patients also receive paracetamol and dexketoprofen. After surgery, patients use a patient-controlled analgesia (PCA) pump with tramadol, and if pain remains high, rescue doses of dexketoprofen are given. Participants will have their pain levels assessed at multiple times up to 24 hours after surgery using the Numerical Pain Rating Scale at rest and while coughing. Researchers will track total opioid use, rescue analgesic use, any complications, and patient satisfaction 24 hours after surgery. This thorough monitoring helps understand the benefits and potential risks of both pain control methods in the early recovery period.

Researchers are evaluating the use of anrikefon, a new type of pain medicine that targets specific receptors related to visceral pain, for managing pain after laparoscopic surgery. This study focuses on patients undergoing laparoscopic colorectal surgery, aiming to find the best dose of anrikefon given through a patient-controlled intravenous analgesia (PCIA) pump. The goal is to specifically reduce visceral pain, which is often underestimated and not well controlled by usual pain medicines like morphine. Participants will receive postoperative pain management with one of four treatments: high-dose anrikefon, medium-dose anrikefon, low-dose anrikefon, or morphine. Each treatment is delivered via a PCIA pump programmed to give an initial dose followed by patient-controlled bolus doses with a lockout period, over 48 hours. The treatments are combined with other pain control methods like nerve blocks for somatic pain and nonsteroidal anti-inflammatory drugs (NSAIDs) for inflammatory pain as part of a multimodal approach. During the study, participants will be monitored closely for pain levels at rest and with movement over 48 hours after surgery using pain intensity measures. Researchers will assess the area under the curve (AUC) of visceral and overall pain to evaluate effectiveness. Safety and side effects will also be observed. The study is designed as a randomized, double-blind, active-controlled trial, helping determine the feasibility of a larger future study and optimal dosing for anrikefon in this setting.

Women undergoing gynecologic oncology surgery often experience significant preoperative anxiety due to concerns about cancer diagnosis, survival, loss of reproductive organs, body image, and sexual health. This anxiety can negatively affect physiological parameters such as heart rate, blood pressure, respiratory rate, and oxygen saturation, increasing surgical risks and discomfort. Researchers are evaluating whether a virtual reality (VR) intervention can reduce this anxiety and improve patient satisfaction before surgery in a randomized controlled trial. Participants will be randomly assigned to either an intervention group receiving a 20-minute virtual reality relaxation session using visual and auditory stimuli delivered via a VR headset, or a control group receiving standard preoperative care. Anxiety levels and physiological parameters will be measured immediately before and after the intervention or standard care session. Patient satisfaction with the preoperative experience will be assessed once immediately after the intervention and before surgery. During the study, women aged 18 years or older with confirmed gynecological cancer scheduled for their first laparotomy surgery will participate. Assessments include anxiety scoring, blood pressure, heart rate, respiratory rate, and oxygen saturation before and after the intervention. Patient satisfaction will be evaluated before surgery. Safety and adherence will be monitored, including observation for any medical complications or withdrawal. The study aims to provide evidence for VR as a nurse-led, non-invasive method to enhance preoperative care in gynecologic oncology surgery.

Researchers are evaluating the effectiveness of the Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for pain relief after laparoscopic renal surgery. This randomized controlled trial involves 66 patients undergoing laparoscopic nephrectomy or partial nephrectomy, with the goal of assessing postoperative analgesia and recovery. The study measures include opioid use, pain scores, comfort, recovery quality, and side effects related to anesthesia. Participants are randomly assigned to one of two groups: the experimental group receives the Anterior Quadratus Lumborum Block using 20 ml of 0.375% ropivacaine hydrochloride administered under laparoscopic direct vision, while the control group receives local infiltration anesthesia with the same dose of ropivacaine. Randomization is done by a clinical researcher using sealed envelopes before surgery. During the study, data collection includes opioid consumption at various postoperative time points up to 48 hours, pain ratings at rest and during activity, comfort and recovery questionnaires, and monitoring for adverse reactions and anesthesia-related complications for up to 72 hours. Length of hospital stay is also recorded for up to 10 days after surgery. Data is carefully recorded in case report forms and maintained in an electronic database, with follow-up assessments to evaluate patient outcomes.