Abdominal Surgery

Researchers are evaluating the use of transversus abdominis plane (TAP) block with different adjuvants to improve pain relief after laparotomy surgery. This study compares the addition of dexamethasone or dexmedetomidine to bupivacaine in patients aged 25 to 65 years with ASA Class I or II status. The goal is to assess which combination provides longer-lasting postoperative analgesia and reduces the need for additional pain medication. Participants will be randomly assigned to one of two groups. Group A receives a TAP block with 18ml of 0.25% bupivacaine plus 2ml of dexamethasone (8mg). Group B receives the same bupivacaine dose plus 2ml of dexmedetomidine (1µg/kg diluted in saline). The TAP block is administered bilaterally under ultrasound guidance immediately after surgery, using a needle guided between the internal oblique and transversus abdominis muscles. Patients are monitored for complications like local anesthetic toxicity or hematoma. During the 24-hour postoperative period, patients' pain levels will be measured using a Visual Analogue Scale (VAS) at several time points. If pain is insufficiently controlled (VAS ≥4), rescue analgesia with IV ketorolac will be provided and the time to first rescue dose recorded. Additional assessments include monitoring nausea, vomiting, heart rate, and blood pressure. The primary outcome is the duration until the first request for rescue analgesia, with secondary outcomes focused on pain scores over 24 hours.

This research aims to improve how appendicitis, a common emergency surgery condition, is managed worldwide by studying different emergency care systems. Appendicitis requires quick diagnosis and treatment to avoid complications. Using appendicitis as a marker, the study looks at access, quality, and efficiency across hospitals in various countries, including low- and middle-income regions, to find ways to enhance emergency surgical care. The study collects data from about 500 hospitals globally between February and May 2025, focusing on patients undergoing appendicectomy using any surgical method, including open, laparoscopic, or robotic approaches. Hospitals will record information for consecutive patients over 14-day periods. The study includes two sub-studies: one on sustainability and waste management in operating rooms and another on the financial impact of surgery on patients, especially in resource-limited settings. Participants will have their care observed through routine health records without extra follow-up visits. Researchers will measure key factors such as time from symptoms to surgical assessment, rates of minimally invasive surgery, complications within 30 days, and hospital stay length. This data will help identify gaps and guide improvements in emergency surgical care worldwide, aiming to make treatment safer, faster, and more affordable.

Researchers are evaluating resectability rates and survival outcomes in patients with borderline resectable and locally advanced pancreatic cancer who receive primary chemotherapy. This nationwide Norwegian single-arm prospective study follows national guidelines for diagnosis, oncological treatment, surgery, and follow-up. The goal is to achieve a 50% resection rate in borderline resectable pancreatic cancer and 15% in locally advanced cases, aiming for adequate overall survival and controlled morbidity and mortality after surgery. Participants will receive primary chemotherapy according to national guidelines, preferably using mFOLFIRINOX or gemcitabine-nab-paclitaxel regimens. Surgical exploration and resection may follow chemotherapy, with surgery scheduled within four weeks after the last neoadjuvant infusion. Surgical procedures include pancreatoduodenectomy, distal pancreatectomy with splenectomy, or total pancreatectomy with splenectomy, possibly involving venous or arterial resection and reconstruction. Diagnostic procedures include endoscopic ultrasound fine-needle biopsy for diagnosis and molecular pathology and optional PET/CT scans at baseline and after two months of chemotherapy. Participants will be assessed regularly with quality of life questionnaires at baseline, 3, 6, and 12 months from diagnosis, then yearly thereafter. Researchers will monitor resection rates, overall survival, mortality and morbidity after surgery, adverse events, and molecular pathology markers. The study collects data from November 2023 through December 2027, with a focus on surgical outcomes and patient well-being following treatment.

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 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.

Researchers are evaluating the safety and effectiveness of the xBar system, a monitoring tool designed to detect post-operative anastomotic leaks in patients undergoing rectal or sigmoid resections with anastomosis. This pivotal, prospective, blinded, multi-center study involves about 190 participants scheduled for colorectal surgery without diversion. The clinical team is blinded to the xBar system's leak detection results to objectively assess its performance. The xBar system is an investigational device consisting of a surgical drain with embedded electrodes connected to a small electronic device that collects and relays data. During the surgery, the xBar device will be placed according to standard procedures, and data recording will continue for at least 3 days after surgery. All patients in the study will receive the xBar device, and safety and complication detection performance will be evaluated by comparing the clinical team's diagnoses with the system's data retrospectively. Participants will be monitored through the study period, which includes follow-up assessments for an average of one year to evaluate safety and performance outcomes. Researchers will measure severe leak rates comparable to standard care, successful device placement, and sensitivity and specificity of severe leak detection. The study involves safety monitoring and retrospective performance evaluation to determine the device's ability to detect complications after colorectal surgery.

Researchers are evaluating an educational handout designed for transgender and non-binary individuals assigned female at birth who are considering gender-affirming hysterectomy with or without ovary removal. The study aims to assess the impact of this handout on patients' understanding of the benefits and risks of retaining or removing ovaries before surgery. This interventional trial is randomized and does not involve masking or blinding. The intervention involves providing an educational handout to a group of participants prior to their surgical consultation at the time of the initial survey. Participants are randomly assigned to either receive the handout plus a survey or just the survey without the handout. This approach allows researchers to compare knowledge and decisional conflict between the groups. Participants will complete surveys to measure their decisional conflict score on the first day of the study. The researchers will monitor how the educational material influences participants' decisions about surgery. The study includes adults aged 18 to 65, with follow-up limited to the initial consultation period. The total duration and further follow-up details are not specified.

Researchers are evaluating a new surgical method called Reduced-Port Fusion Surgery for patients undergoing temporary ileostomy during laparoscopic or robotic colorectal surgery. This study compares this new technique with traditional stoma positioning and surgery methods to see if it can reduce complications, lessen postoperative pain, improve quality of life, and make stoma retraction surgery easier. A total of 80 patients will be randomly assigned to either the new or traditional surgery group. The Reduced-Port Fusion Surgery involves preoperative planning where the stoma therapist and surgeon collaborate to create a joint trocar and stoma fusion point that allows more lateral stoma placement outside the rectus abdominis muscle. During surgery, the main trocar incision is extended to create the ileostomy at this fusion site, allowing dual use of one incision. The control group will receive traditional stoma positioning within the rectus abdominis and conventional ileostomy creation, ensuring the trocar and stoma sites do not overlap. Participants will be monitored for stoma-related complications, skin infection rates, hernia incidence, postoperative pain, and quality of life at 7, 30, and 90 days after surgery. Evaluations include the DET score assessing skin discoloration, erosion, and tissue overgrowth. The study also tracks infection rates at the stoma and trocar sites, parastomal hernia development, and pain levels. Quality of life is assessed at 30 and 90 days. The trial aims to provide detailed safety and effectiveness data over this follow-up period.

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.