Hernia

This research focuses on pregnant women whose unborn babies have been diagnosed with Congenital Diaphragmatic Hernia (CDH), a condition where a hole in the diaphragm allows organs to move into the chest. The study aims to use images taken during routine medical care to create 3D animations and models of the baby and the CDH. These models help parents understand the condition and assist surgeons in planning surgery after birth. The study involves using existing routine scans from pregnant women referred for fetal MRI without any additional intervention. Researchers will create detailed 3D visualizations from these images to better illustrate the size of the diaphragmatic hole and the position of the organs. The study includes patients from diagnosis through to the post-operative period after birth. Participants will be pregnant women attending a fetal medicine unit who have agreed to take part. Researchers will collect baseline information such as patient demographics. The study observes the use of 3D imaging to support clinical management and surgical planning. Participation involves no additional treatment, only the use of images already taken during standard prenatal care. The study is ongoing and will continue until June 2025.

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 laparoscopic/robotic 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.

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 evaluating the safety and effectiveness of sildenafil therapy for pulmonary hypertension (PH) in newborns with congenital diaphragmatic hernia (CDH). CDH is a condition where a defect in the diaphragm allows abdominal organs to move into the chest, affecting lung growth and leading to respiratory failure and PH after surgical repair. This trial aims to better understand how sildenafil, a drug that relaxes blood vessels in the lungs, may help improve heart and lung function in these infants. The study compares two groups: one receiving sildenafil citrate orally at 1mg/kg every 8 hours for up to 14 days, and the other receiving a placebo with the same schedule. Sildenafil works by increasing levels of cGMP in lung vessels to relax them and reduce PH. Treatment starts after surgical repair and an echocardiogram showing elevated left ventricular eccentricity index (LVEI) of 1.4 or higher. The trial uses a randomized, quadruple-masked design to fairly assess the effects. Participants will have echocardiograms before starting treatment and after 14 days to measure changes in LVEI, an indicator of pulmonary hypertension. Researchers will also monitor the need for extracorporeal membrane oxygenation (ECMO), death rates, use of other lung medications, and side effects like low blood pressure or reduced urine output. The study aims to support future larger trials focused on long-term heart and lung health in infants with CDH and PH.

Researchers are evaluating the safety and effectiveness of abdominal wall transplantation to repair abdominal wall defects. This treatment may be done alone or along with another organ transplant. The study involves a small group of participants and aims to assess how well the transplanted abdominal wall restores function. Participants will receive either an isolated abdominal wall transplant or an abdominal wall transplant combined with another solid organ transplant. All participants will be given standard immunosuppression therapy similar to that used in other non-vascularized composite allograft organ transplants. The study will take place over 18 months at Duke University Medical Center. During the 18-month study period, participants will be closely monitored to see if the transplanted abdominal wall remains viable and functional. Researchers will evaluate the success of the transplant and monitor the participants’ health and response to treatment throughout this time. The primary measure is the number of subjects with a viable abdominal wall transplant at 18 months.

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 investigating the levels of two naturally occurring amino acids, Arginine and Asymmetric Dimethylarginine (ADMA), in newborns undergoing abdominal surgery within the first five days of life due to congenital abdominal malformations. The study aims to understand how the relationship between these amino acids may predict recovery and complications after surgery, based on previous findings in adult patients. This observational, physiological study is conducted across two hospitals within the Liverpool Neonatal Partnership.

This research aims to clinically evaluate the Anovo Surgical System in patients undergoing ventral hernia repair. The study focuses on assessing the safety and performance of this robotic system, which has undergone extensive preclinical testing to ensure its integrity. The system is designed to assist surgeons in accurately controlling robotic arms for tissue manipulation during laparoscopic surgery. Participants will undergo robotic ventral hernia repair using the Anovo Surgical System, which features articulated robotic arms to facilitate access and closure of the fascial defect. The procedure involves endoscopic control of instruments for tasks like grasping, dissection, and electrosurgery. This study includes monitoring both intra-operative and post-operative outcomes, including procedure times, adverse events, wound healing, and hospital stay. During the study, participants will be closely monitored with data collected on operative details such as conversion rates, procedure completion, console and docking times, and adverse events related to the device and procedure. Post-operative assessments will continue for about four weeks to evaluate complications like wound seroma and surgical site infections. The study allows for comprehensive safety and procedural outcome tracking up to hospital discharge and throughout the follow-up period.

Researchers are evaluating natural orifice specimen extraction (NOSE), a minimally invasive surgical technique for colorectal surgery where the specimen is removed through natural openings like the anus or vagina instead of an abdominal incision. This prospective multicenter observational registry compares outcomes of NOSE with traditional transabdominal specimen extraction, focusing on long-term results such as incisional hernia risk and patient-reported experiences. The study aims to provide comprehensive data on wound complications, bowel, urinary and sexual function, and cancer outcomes across several centers in the Asia-Pacific region. The study includes two groups: patients planned for NOSE extraction and those planned for transabdominal extraction, both undergoing elective minimally invasive colorectal surgery. Surgical methods, perioperative care, and follow-up remain according to each center’s usual practice without mandated changes. Data on surgical details, complications, and oncologic outcomes are collected prospectively, with patient-reported quality-of-life and functional assessments at multiple time points up to two years after surgery. Participants will be followed for up to 24 months after their surgery to evaluate the time to incisional hernia and other complications. Researchers will collect clinical data, patient questionnaires on quality of life, body image, bowel and sexual function, as well as cancer recurrence outcomes. The study uses validated tools such as EQ-5D-5L, Body Image Scale, and Low Anterior Resection Syndrome score. Data are securely stored and no changes to routine care are required, ensuring participant safety and standard treatment continuity.

This research aims to evaluate the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. It compares ECLIPSIUM, a bioresorbable polymer-based fixation device, to bioresorbable tacks to determine if it can reduce the risk of hernia recurrence. The study is a prospective, multi-center, randomized, single-blind trial designed to assess whether ECLIPSIUM offers clinical benefits in laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures. Participants will receive one of two treatments: the ECLIPSIUM System, which applies a biodegradable polymer coating to the mesh and secures it with photoactivation using a special curing light, or resorbable tacks that fasten the mesh and are absorbed by the body over time. Each participant undergoes laparoscopic ventral hernia repair with mesh fixation using either method. The study will monitor outcomes over 12 months, including hernia recurrence and complications. During the study, participants will have assessments at 6 and 12 months to check for hernia recurrence and any complications. The trial includes follow-up visits and evaluations to monitor safety and effectiveness. Participants will be observed for the cumulative incidence of complications up to 12 months, and the primary outcome measurement is hernia recurrence at 6 months. The total duration of participation will vary depending on individual follow-up schedules.