This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.
The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
Inguinal hernia is operated using open surgery
Inguinal hernia is operated using laparoendoscopic technique
Mikkeli Central Hospital
Mikkeli, Finland
Chronic pain
Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery
Time frame: from 1 week to one year
Complications
Postoperative complications of surgery (wound infection, hemorrhage)
Time frame: 1 month
Recurrence
Hernia recurrences after 5 years
Time frame: 5 years
Sick leave
how many days the patient is not working after surgery
Time frame: 0-30 days
Treatment costs
how much in euros the surgical treatment will cost
Time frame: 0-30 days
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