Hernia
Conditions
Brief summary
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.
Interventions
DEVICEFibrin sealant spray
Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter
DEVICEMechanical stapling
Fixation of mesh would be performed using mechanical staplers
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.
Exclusion criteria
* Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of chronic pain | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Severity of acute pain | 1 week |
| Morbidities | 30 day |
| Recurrence rate | 6 month |
| Quality of life assessment | 6 months |
Countries
Hong Kong
Outcome results
None listed