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Hernia clinical trials

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NCT ID: NCT01955278 Recruiting - Parastomal Hernia Clinical Trials

Role of Prosthetic Mesh in Preventing Parastomal Hernias

RPMPPH
Start date: March 2013
Phase: Phase 3
Study type: Interventional

Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3). Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8). The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support. Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro. Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique. Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period. Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.

NCT ID: NCT01876342 Recruiting - Chronic Pain Clinical Trials

TEP Versus Open Repair of Sportsman's Hernia

sports hernia
Start date: June 2013
Phase: N/A
Study type: Interventional

Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair without mesh or laparoscopic technique with mesh have been advocated in the treatment of sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis is that laparoscopic technique is less painfull than open surgery for repair of sportsman's hernia.

NCT ID: NCT01830452 Recruiting - Hernia, Inguinal Clinical Trials

Less Chronic Pain After Lichtenstein Hernioplasty Using the Self-gripping Parietex Progrip Mesh

HIPPO
Start date: September 2010
Phase: Phase 4
Study type: Interventional

Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%. Many factors influence the onset and persistence of pain. Mesh characteristics and fixation have been pointed as important etiologic factors. This study compares two types of fixation for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this mesh will be fixed with non absorbable sutures. In the study group sutures will not be needed because of self gripping microhooks on the surface of the mesh. Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will be done according to Lichtenstein as described by Amid et all. Included will be all unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the exclusion criteria. Patients will be followed for two years. The main endpoint is the amount of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST). Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay, QOL, return to work and daily activities, genital and sexual problems. To demonstrate a difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is calculated. Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will cause less post-operative and chronic pain without enhancing the recurrence rate.

NCT ID: NCT01799967 Recruiting - GERD Clinical Trials

Minimally Invasive Surgery of the Gastro-esophageal Junction

MISGEJ
Start date: November 2007
Phase:
Study type: Observational

This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.

NCT ID: NCT01797172 Recruiting - Clinical trials for Contained Cervical Disc Herniation

Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?

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

Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal damage. A variety of published studies have demonstrated this treatment to be both safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a popular type of pain treatment. The application of PRF is also a safe and useful intervention for neck pain. Although these treatment types are described in the literature, the available evidence for efficacy is not sufficient to allow definitive conclusions on the optimal therapy to be made. The purpose of this study is to investigate which technique is the most effective in terms of pain relief on short term in patients with contained cervical disc herniation: PCN or PRF?

NCT ID: NCT01640431 Recruiting - Clinical trials for Lumbar Spine Disc Herniation

Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation

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

The purpose of this study was to compare the efficacy of method Lumbar Segmental Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional disability and ability to activate the transversus abdominis (TrA) of individuals with chronic back pain caused by disc herniation.

NCT ID: NCT01638221 Recruiting - Inguinal Hernia Clinical Trials

Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

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

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

NCT ID: NCT01592942 Recruiting - Inguinal Hernia Clinical Trials

Mesh Fixation in Lichtenstein Hernioplasty

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

This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.

NCT ID: NCT01590940 Recruiting - Clinical trials for Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair

Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair

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

The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application. Primary Objective Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate: - Patient report of pain via their Pain score - Wound complication - Incidence of chronic groin pain - Recurrence rate - Other complications Secondary Objectives Record the description and assessment of the Parietex plug and patch hernia system: - surgical technique - description of dissection and mesh placement - method of fixation - operative times, anesthesia choice - length of hospital stay - mesh handling characteristics - return to daily activities - overall patient satisfaction

NCT ID: NCT01589796 Recruiting - Adult Clinical Trials

Medial Versus Traditional Approach to US-guided TAP Blocks for Open Inguinal Hernia Repair

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

Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric nerves.