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More info
You can access this
clinical trial
if you have
Hernia
and you are
between 18 and 70
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS. In this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.

Provided treatments

  • Device: Fibrin sealant spray
  • Device: Mechanical stapling

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01727050. The sponsor of the trial is Chinese University of Hong Kong and it is looking for 129 volunteers for the current phase.
Official trial title:
Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty