Hernia, Femoral, Hernia, Inguinal, Inguinal Hernia, Direct, Inguinal Hernia, Indirect, Neuralgia, Atypical, Neuralgia, Iliohypogastric Nerve, Neuralgia, Ilioinguinal, Recurrence
Conditions
Keywords
laparoscopic inguinal hernia repair, total extraperitoneoscopic hernia repair, transabdominal preperitoneal hernia repair, inguinal hernia, laparoscopy, hernia repair, herniorraphy, laparoscopic surgery
Brief summary
Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.
Detailed description
A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.
Interventions
PROCEDURETEP without fixation
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
PROCEDURETEP with fixation
Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
PROCEDURETAPP without fixation
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation
PROCEDURETAPP with fixation
Standard transabdominal preperitoneal (TAPP) inguinal hernia repair
Sponsors
Muğla Sıtkı Koçman University
Bahçeşehir University
Medical Park Gaziantep Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* unilateral hernia * uncomplicated hernia * medical fitness for general anesthesia
Exclusion criteria
* unfit for general anesthesia * complicated hernia * uncorrectable coagulopathy * BMI \> 35 * concomitant pathologies requiring simultaneous surgery * bilateral hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from preoperative pain levels at 1 week assessed by the VAS | preoperative and postoperative 1th week | neuralgia, inguinal |
| Change from preoperative pain levels at 1 year assessed by the VAS | preoperative and postoperative 1st year | neuralgia, inguinal |
| Change from preoperative pain levels at 6 months assessed by the VAS | preoperative and postoperative 6th month | neuralgia, inguinal |
| Change from preoperative pain levels at 3 months assessed by the VAS | preoperative and postoperative 3th month | neuralgia, inguinal |
| Change from preoperative pain levels at 1 month assessed by the VAS | preoperative and postoperative 1 month | neuralgia, inguinal |
| Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS) | preoperative and postoperative 2nd year | neuralgia, inguinal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| conversion rate | through the first day | conversion to open surgery |
| recurrence rate | up to 24 months | clinical and radiological diagnosed |
| rate of minor and major complications | 2 year | it was assessed as; no complication, minor complications, major complications and complications needed reoperation |
| Total hospital costs | up to 24 months | consisted all costs of hospital stays and outpatient treatments |
Countries
Turkey (Türkiye)
Outcome results
None listed