Evaluating the recurrence rate and adverse events of transversalis muscle fascia repair in total extraperitoneal repair (TEP) of inguinal hernia
Phase 2
Recruiting
- Conditions
- Inguinal hernia.Inguinal hernia
- Registration Number
- IRCT20180312039067N2
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
No history of abdominal surgery below the umbilical line
Primary direct hernia or unilateral or bilateral recurrent hernia
No history of mesh implantation
BMI less than or equal to 40
No history of liver disorder characterized by ascites
No history of renal failure
failure to complete written consent
Exclusion Criteria
Need to repair inguinal hernia with open surgery
Strangulated inguinal hernia
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Operation time. Timepoint: First randomization day. Method of measurement: STOPWATCH.;Hospitalization time. Timepoint: First randomization day. Method of measurement: Documentation in medical records.
- Secondary Outcome Measures
Name Time Method Recurrence. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam.;Pain. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Visual Analogue Scale (VAS) measures pain intensity.;Seroma. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Ultrasonography.;Infection. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam.;Analgesics. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: History taking.