Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- pain one month after surgery
Study Overview
Brief Summary
The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.
Detailed Description
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:
Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.
The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients diagnosed with uncomplicated primary inguinal hernia
- •mentally healthy patients
- •patients without preoperative groin pain
- •patients eligible for outpatient surgery
Exclusion Criteria
- •patients with different surgical diagnosis
Arms & Interventions
Elliptical domed mesh technique
84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
Intervention: Elliptical domed mesh technique (Procedure)
Lichtenstein technique
84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
Intervention: Elliptical domed mesh technique (Procedure)
Outcomes
Primary Outcomes
pain one month after surgery
Time Frame: one month
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain three months after surgery
Time Frame: three months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
pain six months after surgery
Time Frame: six months
Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.
Secondary Outcomes
- dysesthesia one month after surgery(one month)
- dysesthesia three months after surgery(three months)
- dysesthesia six months after surgery(six months)