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Hernia, Ventral clinical trials

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NCT ID: NCT02123719 Completed - Clinical trials for Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.

Laparoscopic Incisional Hernia Repair in Liver Transplant Patients

Start date: January 2013
Phase: N/A
Study type: Observational

Retrospective analysis of patients undergoing laparoscopic incisional hernia repair. Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant. Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate - Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were considered significant.

NCT ID: NCT02076984 Recruiting - Ventral Hernia Clinical Trials

Titanium vs Absorbable Tacks for Mesh Fixation in Laparoscopic Incisional and Ventral Hernia Repair

Start date: June 2014
Phase: N/A
Study type: Interventional

Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies and a recent meta-analysis have reported encouraging results and recurrence rates similar to open repair. The choice of the mesh and fixation methods is of paramount importance during laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for laparoscopic approach represent the first choice in several studies, due to the biomechanical properties and the optimal integration into the abdominal wall. No data with statistical relevance exist on the choice of fixation methods. Primary end point of the present Italian multicentric prospective randomized trial is to evaluate the safety and effectiveness of two different tacks to fix the lightweight polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic spiral tacks (Protack™) vs absorbable "U" shaped tacks (Securestrap™) Design of the Study: 200 patients with ventral hernia will be randomized into two groups: Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack; Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap. Blind randomization will be guaranteed by an on-line software with specific key access for every surgical unit participating in the study. Patients demographics and characteristics, preoperative studies, intraoperative and postoperative results and complications, as well as scheduled follow-up will be recorded and uploaded to the database. Data represented by continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data will be expressed as geometric mean +/- 95% confidence interval. Data representing low incidence events will be expressed as number and percentage of occurrence for each group. Statistical significance for all analyses will be indicated by a p value of 0.05 or less.

NCT ID: NCT02053168 Completed - Ventral Hernia Clinical Trials

A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Start date: February 2014
Phase: N/A
Study type: Interventional

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

NCT ID: NCT02041494 Terminated - Hernia, Ventral Clinical Trials

Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

CVHR
Start date: March 2014
Phase: N/A
Study type: Interventional

Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.

NCT ID: NCT02007096 Completed - Pain, Postoperative Clinical Trials

Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

NCT ID: NCT01987700 Completed - Clinical trials for Hernia of Abdominal Wall

Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.

NCT ID: NCT01981044 Terminated - Clinical trials for Ventral Hernia Repair

SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Start date: September 25, 2013
Phase: N/A
Study type: Interventional

Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.

NCT ID: NCT01962480 Completed - Ventral Hernias Clinical Trials

The Effect of Laparoscopically Closing the Hernia Defect in Laparoscopic Ventral Hernia Repair on Postoperative Pain

CLOSE-GAP
Start date: November 2013
Phase: N/A
Study type: Interventional

Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials. The primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence and chronic pain after 2 years. Material and Methods: A randomized, controlled, double-blinded study is planned. Based on power calculation we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to participate. Conclusion: The technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.

NCT ID: NCT01961687 Completed - Ventral Hernia Clinical Trials

A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Start date: September 2013
Phase: N/A
Study type: Interventional

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

NCT ID: NCT01953302 Completed - Clinical trials for Recurrent Ventral Hernia

Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

Start date: May 2010
Phase: N/A
Study type: Interventional

Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.