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Hernia clinical trials

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NCT ID: NCT02415543 Recruiting - Hernia, Inguinal Clinical Trials

SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery

Start date: March 2016
Phase: N/A
Study type: Interventional

This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve the surgical-related technical details and the device design. In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in the investigators country.

NCT ID: NCT02396940 Recruiting - Hernia Clinical Trials

3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial

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

The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

NCT ID: NCT02387333 Recruiting - Parastomal Hernia Clinical Trials

Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion

Start date: February 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a randomized controlled fashion.

NCT ID: NCT02320071 Recruiting - Hernia, Ventral Clinical Trials

Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair

QualiFunc
Start date: January 2015
Phase: N/A
Study type: Observational

The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia. This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.

NCT ID: NCT02242526 Recruiting - Hiatal Hernia Clinical Trials

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

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: NCT02110186 Recruiting - Clinical trials for Lumbar Disc Herniation

Lumbar Intervertebral Disc Herniation

LIDH
Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare safety and outcomes of the following treatments of lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion. Discectomy with posterior dynamic stabilization is proposed as the most effective treatment to improve range of motion, and to be similarly effective to discectomy alone and discectomy with internal fixation and fusion for other functional outcomes after surgery.

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: NCT02011698 Recruiting - Hernia, Inguinal Clinical Trials

Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial

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

this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy