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Hernia clinical trials

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NCT ID: NCT02240550 Completed - Inguinal Hernia Clinical Trials

A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

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

This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.

NCT ID: NCT02239185 Completed - Clinical trials for Congenital Inguinal Hernia

Laparoscopic Inguinal Hernia Repair in Infancy and Childhood

LIHR-2014
Start date: May 2012
Phase: N/A
Study type: Interventional

Aim of the study The aim of this study is to test the hypothesis that during laparoscopic hernia repair, disconnection of the hernial sac along with suture ligation of the neck is better than transperitoneal purse string suture around the hernial sac at the neck leaving the sac in continuity. Also to compare the two different laparoscopic techniques as regards operative time, recurrence rate, hydrocele formation, and other possible complications as bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic results. ..

NCT ID: NCT02238964 Completed - Hernia Clinical Trials

Reinforcement of Closure of Stoma Site

ROCSS
Start date: November 2012
Phase: Phase 2/Phase 3
Study type: Interventional

ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh (Strattice®) is superior to the standard technique in preventing herniation at 2 years.

NCT ID: NCT02238743 Completed - Hernia Clinical Trials

Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.

ADOPT
Start date: July 2014
Phase: N/A
Study type: Observational

The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.

NCT ID: NCT02233569 Terminated - Hernia, Abdominal Clinical Trials

Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

Start date: November 2012
Phase: N/A
Study type: Interventional

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

NCT ID: NCT02233465 Completed - Parastomal Hernia Clinical Trials

Treating Parastomal Hernia With a Mesh

Start date: January 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Parastomal herniation is difficult to treat. Several different treatment has been tested but still none has revealed to be superior. The use of a mesh has been shown to be a promising way of treating. In this study the investigators will evaluate safety and hernia recurrence rate with a mesh tailored to treat parastomal hernias "Parastomal hernia mesh BARD" in patients with parastomal hernia requiring surgery.

NCT ID: NCT02228889 Recruiting - Hernia, Ventral Clinical Trials

RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

NCT ID: NCT02208557 Recruiting - Incisional Hernia Clinical Trials

Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy

PREBIOUS
Start date: July 2014
Phase: Phase 4
Study type: Interventional

Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.

NCT ID: NCT02206828 Completed - Clinical trials for Ventral Incisional Hernia

The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair

SymCHro
Start date: June 25, 2014
Phase:
Study type: Observational [Patient Registry]

The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).

NCT ID: NCT02177214 Completed - Recurrence Clinical Trials

Magnetic Resonance Imaging of Mesh Position After Ventral Hernia Repair

Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

Purpose of the study is the visualization of the mesh and the determination of the mesh surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to visualize the mesh position in vivo in a safe manner. This provides long-term benefit to early recognize possible recurrence caused by shifting or shrinking of the mesh and to provide early treatment.