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Ventral Hernia clinical trials

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NCT ID: NCT01816867 Completed - Ventral Hernia Clinical Trials

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

Start date: January 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.

NCT ID: NCT01804114 Completed - Ventral Hernia Clinical Trials

Continuous Local Anesthetic Infusion Following Hernia Repair

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

The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.

NCT ID: NCT01794338 Terminated - Ventral Hernia Clinical Trials

The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients

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

This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection. Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables. Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time. The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects. To date there is no evidence to suggest that either mesh type is superior or safer than the other.

NCT ID: NCT01788826 Unknown status - Ventral Hernia Clinical Trials

Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

Start date: June 2009
Phase: N/A
Study type: Interventional

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the primary closure of abdominal incision to prevent incisional hernias. The investigators propose a clinical trial to assess a model to prevent the incisional hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide polypropylene mesh is fixed covering the midline closure; in the control group a conventional closure with a running suture of long-term absorbable material with a suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability during surgery. The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24 months and abdominal CT controls at 6,12, and 24 months. The study will be statistically evaluated with SPSS 18.0.

NCT ID: NCT01761708 Active, not recruiting - Ventral Hernia Clinical Trials

Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch

Re-SITUP
Start date: March 2012
Phase: N/A
Study type: Observational [Patient Registry]

Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.

NCT ID: NCT01741740 Completed - Chronic Pain Clinical Trials

Chronic Complaints After Small Umbilical Hernia Repair

Start date: January 2000
Phase: N/A
Study type: Observational

There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.

NCT ID: NCT01719718 Completed - Ventral Hernia Clinical Trials

The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair

CLOSURE
Start date: October 2012
Phase: N/A
Study type: Interventional

A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomeshâ„¢) in laparoscopic ventral hernia repair.

NCT ID: NCT01639118 Terminated - Ventral Hernia Clinical Trials

Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

SITUP
Start date: March 2012
Phase: N/A
Study type: Observational

Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.

NCT ID: NCT01594450 Completed - Ventral Hernia Clinical Trials

Biological Meshes in Infected Fields: a Randomized Controlled Trial

SIMBIOSE
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.

NCT ID: NCT01589276 Completed - Ventral Hernia Clinical Trials

Risk Factors and Results of Emergency Ventral Hernia Repair

Start date: January 2007
Phase:
Study type: Observational

The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.