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Ventral Hernia clinical trials

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NCT ID: NCT03590184 Recruiting - Ventral Hernia Clinical Trials

Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

Start date: July 1, 2018
Phase:
Study type: Observational

Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus. Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon. In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses. The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months. The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.

NCT ID: NCT03526341 Recruiting - Inguinal Hernia Clinical Trials

Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks

RAFDT
Start date: April 25, 2018
Phase:
Study type: Observational

A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks

NCT ID: NCT03495154 Recruiting - Ventral Hernia Clinical Trials

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

PPDS
Start date: June 21, 2018
Phase: N/A
Study type: Interventional

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

NCT ID: NCT03429374 Not yet recruiting - Ventral Hernia Clinical Trials

Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks (non-absorbable or absorbable) and (fibrin and synthetic) glues. Which fixation technique is superior, is still under evaluation. There is clearly a need for larger trials to obtain confident results on the safety and performance of glue mesh fixation and tack mesh fixation in LVHR. The hypothesis of this prospective, randomized controlled study is that post-operative pain at 4 to 6 weeks after mesh fixation with glue (LiquiBand® Fix 8™) will not differ compared to treatment with absorbable tacks during LVHR. A total of 510 patients will be recruited for this trial. This study will assess: pain, hernia recurrence, safety, procedural characteristics, technical success, analgesic intake, period to return to normal activity and quality of life.

NCT ID: NCT03342040 Recruiting - Ventral Hernia Clinical Trials

Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

Start date: October 15, 2017
Phase: N/A
Study type: Interventional

The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.

NCT ID: NCT03296475 Enrolling by invitation - Ventral Hernia Clinical Trials

Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction

Start date: January 9, 2018
Phase: N/A
Study type: Interventional

Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. AWR surgeons currently do not know if they are applying too much tension when re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause respiratory and cardiac post-operative complications. The investigators propose to study the perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR. In addition, investigators will also analyze the pre-operative patient CT scan to see if there any CT predictors of post-operative cardiorespiratory complications and hernia recurrence. The researchers hypothesize that there is a threshold value or force at which ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of recurrence and cardiorespiratory complications. Method: An in depth biomechanical and physiological study of 18-22 participants with midline ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in which primary fascial closure have been achieved will be included. Any operative technique used to achieve primary fascial closure will be included. Biomechanical and physiological measurements will be taken at five separate stages during the course of the patients' abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will be compared to the patients' pre-operative tests. Meticulous attention will be paid to the study protocol making sure that in each patient the measurements are all taken at the same time and under the same conditions. Discussion: This full biomechanical and physiological work up will enable AWR surgeons to assess when an AWR patient is subjected to too much biomechanical and physiological stress. The abdominal wall tension and strain will be measured to see if this predicts post complications and hernia recurrence.

NCT ID: NCT03283982 Enrolling by invitation - Ventral Hernia Clinical Trials

Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

Start date: September 11, 2017
Phase: N/A
Study type: Interventional

The investigators aim to conduct a registry-based, randomized controlled trial to investigate if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early postoperative pain scores, wound morbidity (surgical site infections, surgical site occurrences and surgical site occurrences requiring procedural intervention), ventral hernia recurrence rate and abdominal wall-specific quality of life.

NCT ID: NCT03255239 Recruiting - Ventral Hernia Clinical Trials

Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

NCT ID: NCT03222102 Recruiting - Clinical trials for Liver Transplantation

Ventral Hernia Prevention After Liver Transplantation

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation. Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix. Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

NCT ID: NCT03133715 Suspended - 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.