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Hernia, Ventral clinical trials

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NCT ID: NCT05606757 Withdrawn - Ventral Hernia Clinical Trials

A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique

Start date: May 7, 2024
Phase: Phase 2
Study type: Interventional

Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens. The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without use of component separation technique (CST) in ventral hernia surgical repair. BOTOX is an investigational drug being developed for the treatment of ventral hernias. In this dose escalation study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States. Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will be followed for approximately 3 months after surgery and will receive a follow-up phone call 30 days (+/-) their last study visit. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05093894 Withdrawn - Ventral Hernia Clinical Trials

Microlyte in Prevention of SSI After Open Ventral Hernia Repair

Start date: December 14, 2021
Phase: N/A
Study type: Interventional

Participants who are scheduled to have open ventral hernia repair (OVHR) will be asked to take part in this study. The purpose of this study is to find out if placing Microlyte (which is a dissolvable sheet coated in silver) on the surgical incision is better than placing nothing on the surgical incision when it comes to decreasing the chance of surgical site infections. The study device has been cleared by the Food and Drug Administration (FDA) for use on surgical incisions. A total of 280 participants will be included in the study. Participation will last for about 90 days.

NCT ID: NCT04580524 Withdrawn - Ventral Hernia Clinical Trials

Phasix Mesh Use in Complex Open Ventral Hernias Study

Start date: April 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).

NCT ID: NCT04143776 Withdrawn - Acute Kidney Injury Clinical Trials

Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction

REPARE
Start date: June 1, 2020
Phase:
Study type: Observational

An incisional hernia is technically challenging to operate and is the most frequent long-term complication after open surgery, resulting in impaired quality of life and reduced physical ability. Large hernias contain large amounts of abdominal volume, which similarly are missing from the abdominal cavity. Due to adaptations of the abdominal wall muscles and decreased space in the abdominal cavity, abdominal wall reconstruction lead to increased tension and thereby increased intraabdominal pressure. Reduced renal and lung function after surgery is one of the leading causes of prolonged hospitalization, increased costs and mortality. Elevated intraabdominal pressure is a known risk factor for kidney injury, but relationships between hernia surgery, increased intraabdominal pressure, renal and lung function are still unclear. Therefore, in patients undergoing surgery for incisional hernia, we will investigate the extent and consequences of elevated intraabdominal pressure, as well as its relation to renal injury and reduced lung function. We will also investigate the relationship between hernia dimensions and the development of increased intraabdominal pressure, as well as identifying patients at particular risk of developing elevated intraabdominal pressure. From April 2020 to October 2021, we will include 100 patients at Bispebjerg Hospital, Denmark, diagnosed with medium to giant incisional hernia, who will undergo scheduled surgery. Patients are followed from before to 30 days after surgery. They will be examined with CT scans before and after surgery. Blood tests, pulmonary function tests and measurement intraabdominal pressure will be performed before and until 3 days after surgery. Thirty days after surgery, lung function tests and blood tests are repeated at a final examination at the out-patient clinic. During follow-up, differences in hospital stay, complications, reoperations, and mortality will be investigated. Participation in the project is not associated with any side effects and risks. The study is expected great scientific gain, as the results can help identify particularly vulnerable patients in need of extended observation and treatment. The results obtained by the project are sought to be published in relevant scientific journals and conferences. The project is expected to extend over a 3-year period, which will include commissioning, data collection, analytical processing, dissemination of results and conduction of PhD thesis.

NCT ID: NCT03484650 Withdrawn - Post Operative Pain Clinical Trials

Systemic Lidocaine Infusion for Pain Control in Ventral Hernia

Start date: January 14, 2020
Phase: Phase 3
Study type: Interventional

Ventral hernia repair leads to more than expected pain. This is thought to be secondary to nerve pain at the lateral transfixion sutures. Systemic lidocaine given pre-op has in other situations decreased neurogenic pain. This study will examine its effects on pain experienced after ventral hernia repair.

NCT ID: NCT03133715 Withdrawn - Ventral Hernia Clinical Trials

Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

NCT ID: NCT02785276 Withdrawn - Pain, Postoperative Clinical Trials

Improving Pain Relief Following Laparoscopic Ventral Hernia Repair

Start date: August 2016
Phase: N/A
Study type: Interventional

Aim The general aim of this study is to improve post-operative pain and reduce morphine consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and. Methods: Patients will be randomised by computer generated random numbers (random permutation) and opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain pump system will be placed in the peritoneal cavity between the onlay mesh and parietal peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h. In the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The infusions will run for 68 hours total. All members involved in patient care (with the exception of one independant research fellow) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of post-operative pain will be performed by visual analogue scale, and total opiate consumption will be collected and converted into morphine equivalents. Health significance: Local anaesthesia has become an important addition to multimodal regimens of analgesia following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration has improved post-operative pain when compared with standard opioid regimens for pain relief. Only one previous study looked at bupivacaine infusions into the hernia sac for three days following LVHR. This study found no improvement in post-operative pain or morphine consumption. We aim to demonstrate improved pain and reduced morphine consumption using an alternative catheter insertion technique and ropivacaine as the desired LA agent.

NCT ID: NCT02730936 Withdrawn - Ventral Hernias Clinical Trials

Antimicrobial Hernia Repair Device

Start date: January 12, 2016
Phase: N/A
Study type: Interventional

This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

NCT ID: NCT02584153 Withdrawn - Ventral Hernia Clinical Trials

A Study of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias Following Abdominal Surgery

HiP_1
Start date: January 2019
Phase: Phase 1
Study type: Interventional

Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts are primarily focused on improving repair materials and surgical techniques to correct these hernias instead of the optimal solution: prevention. A product called MYOSEAL is currently being developed to prevent hernia formation after abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study is to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure in patients undergoing abdominal surgery. The investigators expect that applying this product to sutured myofascial incisions will increase collagen formation in the wound and thus prevent the formation of incisional hernias.

NCT ID: NCT02408458 Withdrawn - Ventral Hernia Clinical Trials

Miromatrix Biological Mesh for Ventral Hernia Repair

MIROMESH PM-1
Start date: June 2015
Phase: N/A
Study type: Interventional

This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.