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Inguinal Hernia clinical trials

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NCT ID: NCT00625534 Recruiting - Pain Clinical Trials

Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy

GENINGHERNIA
Start date: April 2008
Phase: Phase 4
Study type: Interventional

Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia repair anymore. Chronic significant post operative pain is a common, clinically relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as well as pain exposure history is showed to be important in the development of chronic significant post operative pain. The objective of this study is to analyse chronic significant post operative pain and the functional outcome status of patients after laparoscopic repair compared to open repair. Methods: A randomized controlled non-blinded clinical trial is designed to compare open inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic significant post operative pain, pain related sexual function disorders, complications, health related quality of life outcomes, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral or bilateral primary hernia who are candidates for elective surgery and medically fit for general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05 and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in may 2009.

NCT ID: NCT00597194 Completed - Inguinal Hernia Clinical Trials

Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Start date: October 2002
Phase: N/A
Study type: Interventional

We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.

NCT ID: NCT00587704 Completed - Inguinal Hernia Clinical Trials

Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair

PVB
Start date: July 2007
Phase: N/A
Study type: Interventional

Primary aim: 1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair. Secondary aims: 1. Compare VAS pain scores in the two groups of patients over the first 24 hours. 2. Compare opioid intake over the first 24 hours in the two groups of patients.

NCT ID: NCT00568269 Completed - Inguinal Hernia Clinical Trials

Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Start date: November 1996
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

NCT ID: NCT00492804 Completed - Inguinal Hernia Clinical Trials

Elective Neurectomy During Inguinal Hernia Repair

Start date: July 2005
Phase: Phase 2
Study type: Interventional

Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair. It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain. This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.

NCT ID: NCT00451893 Active, not recruiting - Inguinal Hernia Clinical Trials

The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

LJUNO
Start date: December 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes. Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

NCT ID: NCT00423241 Terminated - Pain Clinical Trials

SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Start date: January 2007
Phase: N/A
Study type: Interventional

This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures. *Trademark

NCT ID: NCT00416364 Terminated - Inguinal Hernia Clinical Trials

The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial

Start date: March 2006
Phase: N/A
Study type: Observational

There are a variety of methods to repair inguinal hernias. Each has its advocate and may confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and economics have all been evaluated however none in a randomized blinded fashion. Recently, investigators have attempted to address some of these concerns with new prosthetic materials. The preferred method of repair currently employs a tension free technique using mesh prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal ring. Currently no study has compared these techniques for ease of performance, postoperative pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is uniquely qualified to compare these repairs prospectively and blinded to best assess the most cost effective approach which causes the least pain. A prospective double-blinded randomized trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on quality of life will be assessed serially with the SF 12 which is a validated survey used with serial measures in the acute setting.

NCT ID: NCT00393887 Completed - Inguinal Hernia Clinical Trials

Inguinal Hernia Study Using Biodesign IHM

Start date: March 2007
Phase: N/A
Study type: Interventional

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

NCT ID: NCT00306839 Completed - Inguinal Hernia Clinical Trials

Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia

Start date: February 2006
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures.