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Showing 1-20 of 545 trials
NCT07360691
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
NCT07166172
This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.
NCT07545733
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
NCT04282720
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
NCT07261189
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.
NCT07476560
The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias. The main questions it aims to answer are: Does mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh? Comparison group: Researchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time. Participants will: Be randomized to receive either planar mesh or mesh-suture during hernia repair surgery. Undergo standardized preoperative assessment, including baseline data and QoL scoring. Attend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.
NCT07473583
The goal of this observational study is to learn how the length of pneumoperitoneum during laparoscopic inguinal hernia surgery may affect changes in blood bicarbonate levels. Pneumoperitoneum is the use of carbon dioxide gas to create space inside the abdomen during laparoscopic surgery. The main question this study aims to answer is whether a longer pneumoperitoneum time is associated with changes in blood bicarbonate levels after surgery. Participants are adults undergoing laparoscopic inguinal hernia repair as part of their routine medical care. Researchers will measure blood gas values, including bicarbonate levels, before surgery and again two hours after surgery. The change in bicarbonate levels will be compared with the duration of pneumoperitoneum during the operation. The results of this study may help improve the understanding of metabolic changes that occur during laparoscopic surgery.
NCT07319156
There is no study in the current literature that systematically investigates the extent of upper-extremity proprioceptive impairment in patients with radicular neuropathic symptoms secondary to cervical disc herniation, nor its association with clinical findings. Although existing reviews emphasize proprioceptive deficits in populations with neck pain or cervical spondylosis, no studies specifically address the subgroup of cervical disc-related radiculopathy. This gap in knowledge hinders the integration of proprioceptive assessments with upper-extremity functional outcome measures in diagnostic and rehabilitative processes, suggesting a need for more specific data to guide sensory-motor training approaches. The primary aim of the present study is to assess upper-extremity proprioception in patients with cervical radiculopathy by comparing them with a healthy control group. The secondary aim is to examine the relationship between upper-extremity proprioception and clinical outcomes, including parameters such as pain and functional status.
NCT07461558
This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain. This study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.
NCT07327463
This observational study aims to compare the postoperative analgesic effectiveness of ultrasound-guided transversus abdominis plane (TAP) block and single-dose epidural anesthesia in patients undergoing umbilical hernia surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS) at predefined postoperative time points. The study seeks to determine which analgesic approach provides superior pain control and patient satisfaction in the postoperative period.
NCT07442188
Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide. Despite being classified as a minor surgical intervention, moderate to severe postoperative pain is reported in approximately 60% of patients. In a subset of these patients, acute postoperative pain may persist and evolve into chronic post-surgical inguinal pain, significantly affecting quality of life. In recent years, beyond the use of systemic intravenous analgesics, ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia protocols with the aim of reducing postoperative opioid consumption and improving pain control. However, the current literature does not provide definitive evidence regarding the superiority of one block technique over another in this surgical population. The primary objective of the present study is to compare the analgesic efficacy of the Quadro-iliac Plane Block (QIPB) and the transversus abdominis plane block (TAPB) in patients undergoing inguinal hernia repair.
NCT07451483
Cytoreductive surgery (CRS), with or without hyperthermic intraperitoneal chemotherapy (HIPEC), is currently the standard treatment for advanced peritoneal tumors, including pseudomyxoma peritonei (PMP), colorectal, and ovarian peritoneal carcinomatosis. This complex surgical approach involves extensive resections to remove all visible tumor deposits, often followed by heated intraperitoneal chemotherapy to target residual microscopic disease. While CRS ± HIPEC has been shown to improve survival, it is associated with significant postoperative morbidity, particularly affecting the abdominal wall. One of the most frequent and clinically relevant complications is the development of ventral (incisional) hernias, which can reduce quality of life, limit physical activity, and sometimes require additional surgical repair. The incidence, risk factors, and optimal management of ventral hernias after CRS ± HIPEC remain incompletely defined. Reported incidences vary widely, likely due to differences in surgical techniques, patient populations, definitions of hernia, and follow-up duration. Known contributing factors include extensive laparotomies, multiple resections, tissue fragility induced by hyperthermic chemotherapy, and patient-specific factors such as age and body mass index. Additionally, management strategies for ventral hernias are heterogeneous, ranging from direct fascial closure to reinforcement with synthetic or biological meshes, using different surgical approaches (onlay or sublay), with limited evidence in oncologic settings. This single-center retrospective observational study at the Institut Jules Bordet aims to provide a comprehensive analysis of ventral hernia occurrence, risk factors, and management following CRS ± HIPEC. Adult patients who underwent CRS ± HIPEC for PMP, colorectal, or ovarian peritoneal carcinomatosis between January 1, 2010, and December 31, 2024, were included. Patients with prior ventral hernias, incomplete follow-up (\<12 months), missing data, or interrupted CRS due to extensive disease were excluded. Hernias were identified via clinical examination and imaging studies (CT or MRI), and classified as early (\<12 months) or late (\>12 months) postoperative events. Patients were categorized according to the presence or absence of ventral hernias at the incision site. The primary objective of the study is to determine the incidence of incisional hernias following CRS ± HIPEC. Secondary objectives include (1) identification of patient-related and surgical risk factors associated with hernia development, and (2) analysis of institutional surgical management strategies, including type of repair and timing of intervention. Data were collected retrospectively from medical records, and statistical analyses include descriptive statistics, survival analysis, and univariate and multivariate regression to identify independent risk factors for hernia development. This study is expected to provide valuable insights into the epidemiology, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, contributing to improved postoperative care, informed surgical planning, and potentially guiding institutional and international recommendations for hernia prevention and repair in this high-risk population. This study aims to provide a comprehensive understanding of the occurrence, risk factors, and management of ventral hernias in patients undergoing CRS ± HIPEC, which may help guide surgical practice and improve postoperative outcomes.
NCT07434687
The goal of this clinical trial is to learn if one of two surgical techniques works better for treating paraumbilical hernias in adult men and women between 18 and 65 years old. The main questions it aims to answer are: Does one technique lead to fewer complications after surgery, such as infection or fluid buildup (seroma)? Does one technique result in less pain or a shorter operating time? Researchers will compare the ETEP repair group to the SCOLA repair group to see if one method leads to better outcomes for patients. Participants will: Be randomly assigned to receive either the ETEP or SCOLA surgical repair. Have their surgery and recovery tracked by the research team. Attend follow-up visits for up to six months to check for any complications.
NCT06879912
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
NCT07429708
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. According to Davin et al., approximately 80% of patients undergoing lumbar laminectomy experience postoperative discomfort, with 20% developing persistent postsurgical pain (PPSP). The application of erector spinae plane (ESP) block in lumbar laminectomy surgery significantly reduces postoperative pain and hospital length of stay. However, ESP block without adjuvants has limitations in duration. Adjuvants are thus required to optimize the effects of ESP block 4. Dexamethasone is a glucocorticoid that is widely used in the perioperative setting. Interfascial administration of dexamethasone has been shown to prolong the duration of analgesia provided by the peripheral nerve blocks. Pehora et al (2017) reported that perineural dexamethasone with local anesthetics prolongs sensory blockade, effectively reducing postoperative pain intensity and opioid consumption. Its analgesic effects likely stem from anti-inflammatory mechanisms, including supression of proinflammatory cytokines, induction of anti-inflammatory cytokines, reduced prostaglandin synthesis, and decreased neuronal excitability 5 6. Adjuvant dexamethasone provides additional benefits, including prolonged analgesia, reduced pain scores, lower postoperative opioid requirements, and decreased inflammation in patients undergoing lumbar laminectomy. Prior literature has not examined the benefits of dexamethasone as an adjuvant for lumbar ESP block, nor measured and compared inflammatory biomarkers with its use. Therefore, this study investigates the efficacy of dexamethasone adjuant in ESP block for lumbar laminectomy surgery by assessing postoperative prostaglandin E2 levels, analgesia duration, pain scores (VAS) at 8, 12, 16, and 24 hours postoperatively, and patient-controlled analgesia (PCA) fentanyl requirements at the same intervals.
NCT07424417
This prospective randomized controlled trial aims to evaluate the effect of different upper extremity positions on intraocular pressure (IOP) in adult patients undergoing open inguinal hernia repair under spinal anesthesia. Participants will be randomly assigned to one of three arm positions: adduction alongside the body, 90° abduction, or arms crossed over the chest. IOP will be measured using a Tono-Pen AVIA tonometer at predefined intraoperative time points. Hemodynamic parameters including mean arterial pressure, heart rate, and oxygen saturation will also be recorded. The primary outcome is the change in intraocular pressure over time among the three groups. The findings of this study may provide clinically relevant data regarding the impact of upper extremity positioning on ocular physiology during spinal anesthesia.
NCT07423910
Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission. The PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care. The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up. The aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.
NCT07422441
People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.
NCT07422584
This is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and physiologic consequences of high-tension closure. The study includes three cohorts: 1) Healthy controls (N=5), 2) High-tension fascial closure AWR patients (N=10), 3) Low-tension fascial closure AWR patients (N=10). Fascial closure tension will not be altered for the purpose of the study and will be determined by the operating surgeon as part of routine clinical decision-making.
NCT04718168
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.