Inguinal Hernia Unilateral
Conditions
Keywords
Lichtenstein, inguinal hernia repair, mesh fixation, postoperative pain, inguinodynia, surgical site infection, visual analogue scale
Brief summary
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.
Detailed description
The two techniques of mesh fixation include sutures and staples.
Interventions
PROCEDUREMesh fixation with Staples
2 staples will be applied directly over the pubic tubercle, while 3-4 staples will be used to fix the mesh over the inguinal ligament 1-2cm apart. Another 2-3 staples will secure the mesh to the conjoint tendon, and 1 staple lateral to the cord at the deep ring.
PROCEDUREMesh Fixation with Sutures
Polypropylene sutures will be used to fix the mesh, with continuous suturing over the pubic tubercle and inguinal ligament, and interrupted suturing along the posterior wall and deep ring.
Sponsors
Huzaif Saeed Khan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult male patients aged 18-75 years with uncomplicated unilateral inguinal hernia undergoing elective open Lichtenstein mesh repair
Exclusion criteria
* Recurrent hernias * ASA (American Society of Anaesthesiologists) class III or greater * Patients with active obstructive lower urinary tract symptoms * Accidental per-operative nerve injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inguinodynia | 3 and 6 months postoperatively | Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain. |
| Surgical site infection | within 30 days of surgery | Assessed using Southampton Surgical Site Infection grading system |
| Wound Hematoma | Within 30 days postoperatively | Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically |
| Wound Seroma | within 30 days postoperatively | Collection of clear fluid at the operative site, diagnosed clinically as a fluctuant, non-tender swelling at the surgical site |
| Scrotal edema/hematoma | within 30 days postoperatively | Swelling or collection of fluid/blood in the scrotum, identified clinically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | Within 6 months of surgery. | Clinically apparent swelling/bulge in the groin, diagnosed by clinical assessment, at the previously operated site |
| Operative time | During procedure | Time in minutes from skin incision to completion of skin closure |
Countries
Pakistan
Outcome results
None listed