Inguinal Hernia

Researchers are evaluating the use of local versus general anesthesia for inguinal hernia repair in Veterans aged 60 years and older. This pilot study aims to gather data to plan a larger, multisite randomized clinical trial by testing study procedures, recruiting participants, and measuring relevant outcomes. The study also seeks to identify barriers to wider use of local anesthesia and to provide training in clinical trial design and conduct. Participants are randomly assigned to one of three groups open inguinal hernia repair with local anesthesia, open inguinal hernia repair with general anesthesia, or laparoscopicrobotic hernia repair with general anesthesia. Local anesthesia involves injecting a mix of lidocaine with epinephrine and Marcaine at the surgical site along with intravenous sedation and pain medication. General anesthesia uses inhaled and intravenous anesthesia. The laparoscopic or robotic approach is included as it cannot be performed using local anesthesia. During the 6-month study period, participants will undergo surgery and anesthesia as assigned, followed by evaluations at various time points including baseline, 48 hours, 2 weeks, and 6 months after surgery. Researchers will collect data on enrollment rates, participant retention, time to complete assessments, satisfaction, pain levels, cognitive function, delirium, postoperative complications, and recovery times. This information will help refine study instruments and inform the design of future larger trials.

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.

This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.

Researchers are investigating the effects of different physical activity guidelines following surgery for single-sided inguinal hernia repair. This pilot study compares outcomes between patients given standard lifting restrictions and those allowed to return to activity based on their comfort. The goal is to see if allowing patient autonomy can reduce recovery time while monitoring complications, hernia recurrence, physical activity levels, and quality of life. Participants will be randomly assigned to one of two groups after surgery a control group following standard precautions lifting no more than 20 pounds for 6 weeks after open surgery or 2 weeks after minimally invasive surgery, or a treatment group advised to resume activities as tolerated but to stop if pain occurs. Surgery will be performed according to usual medical care. Data will be collected through pre- and post-operative questionnaires, clinical visits, and medical chart reviews. Throughout the study, participants will be assessed on their surgical recovery, timing of return to physical activity, and overall quality of life. Researchers will monitor hernia recurrence and post-surgery complications for up to two years. Questionnaires about activity levels will be completed within six weeks after surgery. All data will be securely stored and analyzed to compare outcomes between the two groups.

Researchers are evaluating the safety and performance of the ECLIPSIUM device in securing mesh during laparoscopic ventral hernia repair. This study compares the ECLIPSIUM System, a bioresorbable polymer-based fixation device, with bioresorbable tacks, to see if it can reduce the risk of hernia recurrence. The trial is designed as a prospective, multi-center, randomized, active control, single-blind non-inferiority study to assess these devices in patients undergoing this surgical procedure. The ECLIPSIUM System works by applying a biodegradable polymer coating to the mesh and activating it in place with a special light to secure the mesh to the abdominal wall. The comparator group uses resorbable tacks, which are surgical fasteners that dissolve over time as the tissue grows into the mesh. Both devices are used during laparoscopic intraperitoneal onlay mesh ventral hernia repair. Participants receive one of these fixation methods during their surgery. Participants will be evaluated for hernia recurrence at 6 and 12 months after surgery as the primary outcome. The study will also monitor complications for up to 12 months. Throughout the trial, participants will follow study instructions, attend scheduled visits, and complete assessments. The total participation duration extends to at least 12 months post-surgery to measure safety and effectiveness outcomes fully.

Researchers are investigating the effects of a categorized physical therapy program on people with non-arthritic hip and groin pain. This study addresses a gap in current research, which has mostly focused on osteoarthritis of the hip, by exploring how a standardized physical therapy approach can help those without arthritis-related hip problems. The trial is randomized and aims to better understand treatment options for hip and groin pain. Participants will be assigned to one of two groups one receiving standard-of-care physical therapy, and the other receiving matrix-based physical therapy in addition to the standard care. Matrix-based therapy involves tailoring stretches and strengthening exercises based on the patients hip mobility and strength. Both approaches will be monitored over the course of the study. Throughout the study, participants will be evaluated using the International Hip Outcome Tool-12 iHOT-12 for up to 6 months to measure hip function and health. Pain levels will be assessed with a numerical rating scale, and adherence to home exercise programs will be tracked. The study includes double-masked procedures to reduce bias and will provide detailed monitoring of participants progress and response to therapy.

Pelvic pain is a common but often under-reported condition in healthy adults, occurring more frequently in women than in men. Many individuals with pelvic pain may underestimate its severity, yet chronic pelvic pain can be managed successfully if diagnosed promptly. This observational study analyzes prospective clinical data to evaluate the prevalence and management of pelvic pain in adults, focusing on treatment outcomes and complications. The study includes adult patients experiencing chronic pelvic, inguinal, sacroiliac, coccygeal, or piriformis pain. It examines the use of various multimodal analgesia methods alongside rehabilitation therapy as behavioral interventions. The research observes the types of rehabilitation therapy used and their effects on pain management without assigning specific treatment groups. The study follows patients over time to analyze outcomes. Participants will be assessed using the Numeric Pain Rating scale over a 12-month period to objectively measure pain levels. Researchers will collect clinical data on treatment types, rehabilitation therapies, and any complications. As an observational study, participants usual care continues while data is gathered to understand pain management better. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are studying pain management techniques for patients undergoing inguinal hernia repair, a common surgical procedure. Despite being classified as minor surgery, many patients experience moderate to severe pain after the operation, with some developing chronic pain that impacts their quality of life. This study aims to compare two ultrasound-guided nerve block techniques, the Quadro-iliac Plane Block QIPB and the transversus abdominis plane block TAPB, to see which provides better pain relief. Participants will be randomly assigned to receive either the TAPB or QIPB procedure under ultrasound guidance during their hernia surgery. Both procedures involve injecting 30 ml of 0.25% bupivacaine to block pain signals, with TAPB performed while lying on the back and QIPB while lying on the side. These blocks are intended to be part of multimodal pain control during and after surgery. During the study, researchers will monitor pain scores for up to 24 hours after surgery and assess patient satisfaction at the 24-hour mark. Patients will be observed in a controlled setting during and after the procedure to evaluate the effectiveness of each nerve block. The study includes adults aged 18 to 65 undergoing unilateral inguinal hernia repair under general anesthesia, and participation lasts through the immediate postoperative period.

This research investigates the early recovery after laparoscopic repair of bilateral inguinal hernias using either conventional laparoscopic surgery l-TAPP or robot-assisted laparoscopic surgery r-TAPP. The study compares these two minimally invasive methods, with or without the injection of local anesthetics at the trocar wound sites, to better understand postoperative outcomes. The purpose is to evaluate differences in recovery and quality of life, as well as safety and recurrence rates after surgery. Participants will be randomly assigned to one of four groups conventional laparoscopic repair with or without local anesthetics, or robot-assisted laparoscopic repair with or without local anesthetics. Both surgical approaches use a self-fixating mesh placed in the pre-peritoneal space. The study is conducted at the Maria Middelares hospital with 200 adult patients over a 24-month inclusion period. Patients will be blinded to which surgical method they receive. During the study, participants will complete quality of life questionnaires before surgery, and again at 1 and 12 months postoperatively. Clinical follow-up will assess early postoperative recovery and hernia recurrence. The main outcome measured is the change in the Post Anesthetic Discharge Scoring System PADSS score within 24 hours after surgery. Researchers will also monitor quality of life and recurrence rates. The total study duration extends until December 2029.

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.