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 1gkg 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 PETCT 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 and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are collecting data to assess the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories during hepatopancreaticobiliary HPB and foregut surgeries. These surgeries include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study is designed as a prospective, single-center investigation focusing on these procedures. Participants will be grouped into four stages based on their diagnosed condition, with each participant undergoing one surgical operation using the da Vinci SP Single-Port Robotic Surgical System. Stage One includes patients undergoing cholecystectomy or hiatal hernia repair with fundoplication. Stage Two involves gastrectomy or distal pancreatectomy. Stage Three covers pancreaticoduodenectomy or esophagectomy, and Stage Four includes hepatectomy. The robotic system is designed to enable minimally invasive single-port surgery through a surgeon console, vision cart, and patient cart with camera and instruments. During the study, participants will be monitored through various assessments including operative time, blood loss, intraoperative and postoperative complications, physical status, survival, disease recurrence, and readmission rates. Follow-up evaluations occur up to five years to track outcomes such as adverse events, positive resection margins, lymph node yield, and overall survival. Participants are followed closely after surgery through hospital discharge and at scheduled intervals to provide comprehensive safety and performance data for the system.

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 37C 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 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.

Researchers are evaluating the safety and effectiveness of Zavicefta in patients with difficult infections in the abdomen, urinary tract, and pneumonia, including infections possibly acquired during hospital stays. This observational study follows regulations by the Ministry of Food and Drug Safety MFDS in Korea and focuses on real-world use after Zavicefta is released in the Korean market. The study aims to collect data on adverse events and treatment responses during routine clinical practice. The study involves patients who have been given at least one dose of Zavicefta for approved infections such as complicated intra-abdominal infection, complicated urinary tract infection including pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia, and other infections caused by aerobic Gram-negative bacteria with limited treatment options. Patients receiving Zavicefta for the first time are included. The study period covers monitoring from the first dose and continues for at least 28 days post-treatment, with follow-up up to one year for clinical response assessment. Participants will be observed during their usual medical care while data is collected on any adverse events or drug reactions, including both expected and unexpected effects. Researchers will track the number of patients reporting adverse events and evaluate treatment outcomes such as clinical cure rates. This post-marketing surveillance study continues for six years after Zaviceftas approval to ensure ongoing safety and effectiveness monitoring in real-world settings.

Researchers are evaluating the REBUILD Bioabsorbable device to assess its safety and performance in patients undergoing open, elective, intent-to-cure laparotomy procedures for cancer treatment. This prospective, non-randomized, multi-center study aims to generate descriptive data on how REBUILD distributes suture tension in abdominal wall closures in oncology patients. The study focuses on device-related adverse events and the integrity of the abdominal wall over one year. Participants will have their abdominal wall closed using the REBUILD Bioabsorbable device combined with a surgeons choice of suture during their standard oncologic laparotomy procedure. The study is single-arm, meaning all participants receive the same investigational device without comparison to other treatments. The devices performance will be monitored over a 12-month period after surgery. During the study, participants will be followed up to assess safety and effectiveness. The primary safety outcome is the occurrence of device-related adverse events within 12 months. The primary performance outcome is evaluated through clinical abdominal examinations and, if available, CT scans within 12 months to confirm the abdominal walls integrity. Participants are expected to comply with follow-up visits and study requirements for the full duration of the study.