Surgery Complications

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

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 compare the effectiveness of topical lignocaine ointment versus 0.2% glyceryl trinitrate (GTN) ointment for reducing postoperative pain and promoting wound healing in patients undergoing hemorrhoidectomy. Hemorrhoids are swollen veins in the anal area, and pain after surgery can delay recovery and affect comfort. The study focuses on determining which ointment provides better pain relief and wound healing outcomes following hemorrhoid removal surgery. Patients undergoing hemorrhoidectomy will be randomly assigned to one of two groups. One group will receive lignocaine ointment applied locally to the anal wound three times daily after surgery, while the other group will receive 0.2% GTN ointment on the same schedule. Both groups will receive standard postoperative care including sitz baths, stool softeners, and paracetamol for pain relief. The study will follow participants for 3 to 6 months overall, with treatment and monitoring focused on the first month after surgery. Participants will have their pain levels assessed using a visual analog scale (VAS) at various times after surgery, including 6, 12, 24, 48, and 72 hours, as well as at 7, 14, 21, and 28 days. Wound healing time will be tracked up to one month, and patient satisfaction will be measured at 6 weeks using a 5-point scale. Additional monitoring includes recording the time to first analgesic request, analgesia amounts, and any side effects such as wound secretion, itching, bleeding, or headaches. Data will be analyzed to compare outcomes between the two ointments.

Researchers are evaluating an AI-assisted digital health tool called the "Smart family doctor" to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted "Smart family doctor" app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the intervention's impact over the 6 months.

Failure to rescue refers to preventable deaths after surgery due to delays in identifying and treating complications. This research aims to evaluate whether a quality improvement intervention called '5 Rs to Rescue' can enhance monitoring and care for surgical patients in hospitals across four African countries: Ethiopia, South Africa, Tanzania, and Uganda. The study uses a multi-center, cluster trial design with mixed methods to assess the intervention's impact on reducing postoperative deaths. The '5 Rs to Rescue' intervention focuses on five key areas: assessing risk with the ASOS risk score, recognizing patient deterioration through regular vital signs and an Early Warning Score system, responding promptly using care pathways for common complications, reassessing patients after deterioration, and reflecting on care during regular meetings. This complex intervention is implemented in participating hospitals to improve patient surveillance after surgery. Participants are adults aged 18 and older who have surgery and receive postoperative care on study wards. Researchers will monitor the effectiveness of the intervention by reporting site-specific findings related to reducing in-hospital deaths within 72 hours after surgery. The study includes process evaluations and ongoing reflections to understand how the program works in practice. Participation involves routine monitoring and data collection during the postoperative period, with study completion expected by September 2026.

Researchers are evaluating patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) to study the safety, effectiveness, and feasibility of using indocyanine green (ICG) near-infrared imaging tracing during 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer. This prospective, single-center, randomized controlled trial compares three surgical approaches to determine if the addition of ICG imaging and 3D visualization improves outcomes, focusing on disease-free survival over three years. Participants will be randomly assigned to one of three groups: Group A receives ICG near-infrared imaging with 3D plus ultra high resolution laparoscopic gastrectomy and lymph node dissection; Group B receives ICG imaging with ultra high resolution laparoscopic gastrectomy and lymph node dissection; Group C undergoes 3D laparoscopic gastrectomy with lymph node dissection without ICG. The study plans to enroll 702 patients and follow them from surgery up to three years to assess long-term outcomes. During the study, patients will undergo surgery according to their assigned group, and researchers will collect data on operation time, number and status of lymph nodes removed, postoperative recovery, complications, immune response, nutritional status, quality of life, and survival rates. Follow-up includes pathology reports shortly after surgery and regular assessments over three years to measure disease-free survival and overall health. The study will also monitor secondary outcomes related to lymph node analysis and patient recovery.

This research aims to compare the safety and effectiveness of two drugs, Ramosetron and Loperamide, for treating Low Anterior Resection Syndrome (LARS), a condition occurring after surgery for mid and low rectal cancer. The study focuses on patients who have undergone surgery and ileostomy repair, assessing improvements in major LARS symptoms. The trial is a multicenter, randomized, and controlled study sponsored by Seoul National University Hospital. Participants will be randomly assigned to receive either Ramosetron or Loperamide. Ramosetron is administered as a drug over a 4-week period. The study uses a quadruple masking design to ensure unbiased results. Both treatments are evaluated over this timeframe to compare their effects on LARS symptoms and patient quality of life. During the study, participants will be assessed at the start and after 4 weeks to measure the severity of major LARS and quality of life using the EORTC QLQ-C30 questionnaire. Researchers will monitor symptom improvement and evaluate safety. The total participation time aligns with these 4-week treatment and assessment periods, focusing on changes in LARS and quality of life scores.

Researchers are evaluating the medium-term performance and safety of two types of dental implants: the Straumann PURE 2-piece Ceramic Implant made of zirconia and the Straumann Bone Level Implant made of titanium. The study aims to compare these implants using a fully digital workflow to understand their biological and technical complications, patient satisfaction, and aesthetic outcomes over a five-year period. Titanium implants have a metallic color that often requires deeper placement, which can complicate hygiene, while zirconia implants offer a color closer to natural teeth. Participants will receive either the zirconia ceramic implant or the standard titanium implant placed in healed extraction sites in the premolar-to-premolar area of the upper or lower jaw for single tooth replacement. After implant placement, prosthetic loading with a definitive crown will occur following a six-month healing period. Both groups undergo routine treatment, with the only difference being the implant material. The surgical approach follows guidelines for healed extraction sites approximately 16 weeks after tooth loss. During the five-year follow-up after implant loading, participants will attend scheduled visits where researchers will measure bone level changes, implant survival rates, and complication-free survival. Patient satisfaction and oral health impact will also be assessed using questionnaires. Data will be collected and analyzed to compare long-term implant performance and safety. Participation involves regular evaluations to monitor outcomes and ensure safety throughout the study duration.

This research aims to evaluate the use of a specialized imaging technique called 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide surgery for medullary thyroid carcinoma (MTC). Surgery is currently the only curative option for MTC, but existing imaging methods and calcitonin tests are not sufficient to fully map the disease. This study focuses on whether 68Ga-TCR-FAPI PET/CT can better identify the extent of MTC and improve surgical planning. Participants are divided into three groups: those newly diagnosed with MTC, those with recurrent or persistent MTC after prior treatment, and those with distant or unresectable lesions but still recommended for surgery. Surgery will be performed based on the lesion range revealed by the 68Ga-TCR-FAPI PET/CT scan, aiming to remove all identified lesions when possible. The surgical principles follow current standards, including lymph node dissection when needed. During the study, researchers will measure calcitonin levels one month after surgery as the primary outcome. Secondary outcomes include two-year event-free survival, how often surgical plans change based on imaging results, and the accuracy of 68Ga-TCR-FAPI PET/CT in detecting MTC lesions. Participants will undergo PET/CT scans, surgery guided by imaging findings, and follow-up assessments to monitor outcomes and safety up to two years after surgery.

Researchers are evaluating treatments for low anterior resection syndrome (LARS), a condition affecting bowel function after part of the rectum is surgically removed in rectal cancer patients. LARS can cause symptoms like urgency, incontinence, frequent bowel movements, constipation, and incomplete emptying. This trial compares a bowel management program using a retrograde rectal enema (RRE) with standard medical management to determine which approach better manages LARS symptoms. Participants are randomly assigned to one of two groups. One group receives a combination of medical management—including fiber, loperamide hydrochloride, and pelvic floor physical therapy—plus a self-administered RRE enema regimen for one year. The other group receives medical management alone for one year and may be referred for surgery if symptoms persist. Abdominal x-rays may be performed during the trial for participants using the RRE. Throughout the study, participants will be assessed using a validated LARS scoring tool and surveys to measure fecal incontinence and patient satisfaction up to one year after treatment starts. Follow-up visits occur at one month, three months, and one year after completing the intervention. The trial aims to evaluate effectiveness, feasibility, and symptom control of the treatments over this period.