A Multicenter Belgian Trial of Ventral Hernia Repair
Ventral HerniaPatients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal width of 8 cm, treated according to the standard practice of the participating investigators. Patients can be treated with the following ventral hernia repair approaches: Laparoscopic ventral hernia repair with closure of the defect (IPOM+) Open ventral hernia repair with closure of the defect (retromuscular repair) Robotic ventral hernia repair with closure of the defect (retromuscular repair) To evaluate the total number of days spent in the hospital within a period of 90 days post-operative. This will be calculated by adding the hospital length of stay for initial surgery or index-procedure, length of stay for any additional readmission resulting from the surgery or re-interventions, and emergency room visits resulting from the surgery or Serious Adverse Event (SAE) related to the index-procedure. Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open and robotic ventral hernia repair.
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
Disc HerniationThe aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. The main hypotheses are: Is there a difference between the sleep quality of patients who listen to white noise and those who do not? Is there a difference between the comfort levels of patients who listen to white noise and those who do not? Is there a difference between the satisfaction levels of patients who listen to white noise and those who do not? The main tasks that the participants will be asked to do will be explained and Their informed consent will be obtained. The two research groups will be compared.
Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
Inguinal Herniathe study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
T-GENVIH-003 LTFU (Long Term Follow Up) Study
HerniaHernia5 moreThe T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.
Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in...
Incisional Hernia After Midline LaparotomyThe aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic HerniaThis is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Prophylactic Mesh in Cytoreductive Surgery
Incisional HerniaEvaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.
Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant...
Incisional Hernia of Anterior Abdominal WallStudy Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation. Study procedures: Consenting patients will be divided into two matched groups: CONTROL group - receiving a standard running fascial closure with PDS suture TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site. There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision. An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.
Patient-reported Outcomes for Patients Undergoing Surgery at Shouldice Hospital.
HerniaBackground: Previous publications have highlighted limited data on patient outcomes and experiences at Shouldice Hospital. Existing studies from Europe reported outcomes following Shouldice repair but lacked recent data. The current project seeks to optimize patient care and knowledge through systematic follow-up. Study Objectives: Establish a patient-reported outcome measure follow-up program. Evaluate postoperative complication rates. Determine important outcomes to patients. Establish and monitor patient satisfaction with decision-making and hernia repair. Hypotheses/Research Questions: Several research questions related to patient motivations, outcomes, knowledge, and satisfaction are posed for investigation. Potential Risks and Benefits: No anticipated risks to participants. Participants won't directly benefit but contribute to improving patient care and knowledge. Study Design: The study employs a prospective follow-up approach. Surveys are sent at specific intervals (30-40 days, 1-year, 3-years, and 5-years) via email. Consent forms are included in the email, allowing participants to choose their level of involvement. Data is collected from survey responses, patient charts, and operative notes. Study Population: All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible. Exclusion criteria: Lack of an email address. The required sample size is unknown, and this study serves as a pilot. Data Collection: Data is collected from surveys, patient charts, and operative notes. Consent is obtained through deferred consent (initial contact via email, with consent forms provided). Safeguards are in place to protect personal health information. Duration of Study: Estimated to take 5-6 years. Recruitment/enrollment: 6-12 months. Follow-up: 5 years from the last enrolled participant. Data analysis and write-up: 5 months. Overlap with Other Projects: Concerns about overlap with other studies are addressed, and concurrent participation is allowed. Participants can withdraw at any time. In summary, this research project aims to gather comprehensive data on hernia surgery outcomes, patient experiences, and satisfaction at Shouldice Hospital through a systematic follow-up approach, contributing to the improvement of patient care and knowledge in this field.
Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia...
Congenital Diaphragmatic HerniaAcute Kidney Injury3 moreThe main aim of this project is to elucidate the incidence of acute kidney injury (AKI) in newborns with congenital diaphragmatic hernia during stay in the Pediatric intensive care unit. (PICU). This patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. Characterization of risk factors to AKI will also be performed.