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Hernia clinical trials

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NCT ID: NCT01635868 Completed - Clinical trials for Ventral Hernia Midline

The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

ABSNOME
Start date: December 2012
Phase: N/A
Study type: Observational

Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence. Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses. Results 1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P<0.001). Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.

NCT ID: NCT01629485 Completed - Hernia Clinical Trials

Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair

Start date: September 2011
Phase: N/A
Study type: Interventional

The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.

NCT ID: NCT01622725 Completed - Clinical trials for Primary and Secondary Ventral Hernia

Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

TIGR
Start date: February 2013
Phase: N/A
Study type: Interventional

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result. The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen. The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study). Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.

NCT ID: NCT01622712 Completed - Clinical trials for Unilateral Inguinal Hernia

Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device

REBOUND
Start date: February 1, 2013
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial. Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.

NCT ID: NCT01622218 Completed - Inguinal Hernia Clinical Trials

The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.

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

The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.

NCT ID: NCT01622127 Completed - Clinical trials for Primary Ventral and Incisional Hernia Repair

Progrip Ventral Study for Sublay Repair

Start date: February 2012
Phase:
Study type: Observational

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair. Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

NCT ID: NCT01607801 Completed - Umbilical Hernia Clinical Trials

Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

UMBI-REC
Start date: January 2007
Phase: N/A
Study type: Observational

background Operation for small umbilical hernias is one of the most common surgical procedures, but the best surgical technique, including the choice of suture or mesh remains unknown. It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the risk of incisional hernias and wound healing problems.It has also been found that the use of resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use of the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx. 1-3%) than sutured repair (10-12 %). However, the scientific literature is deficient, with few patients. The purpose of this study is to describe reoperation rate of recurrence after small umbilical hernias, depending on choice of sutures in both regular repair and in mesh repair. Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with other types of sutures, whereas mesh repair has even lower recurrence rates in small umbilical hernia repairs.

NCT ID: NCT01606449 Completed - Clinical trials for Paraesophageal Hernia

Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia

Start date: January 1980
Phase: N/A
Study type: Observational

Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series. Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.

NCT ID: NCT01597011 Completed - Chronic Pain Clinical Trials

Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

Start date: July 2012
Phase: N/A
Study type: Observational

In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated. The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples. The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.

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.