Department of Surgery, Prince of Wales Hospital
Hong Kong
NCT Number: NCT01727050
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter
Fixation of mesh would be performed using mechanical staplers
Time frame: 6 months
Time frame: 1 week
Time frame: 30 day
Time frame: 6 month
Time frame: 6 months
Chinese University of Hong Kong
Other
Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty
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