Hernia Clinical Trial
Official title:
Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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