Inguinal Hernia Unilateral
Conditions
Keywords
Inguinal hernia, Mesh fixation, Titanium tacker
Brief summary
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation. Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use. Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.
Interventions
OTHERTitanium tacker
Mesh fixation with Titanium tacker
OTHERPolypropylene 0
Mesh was sutured and fixed with polypropylene 0
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 21 years * American Society of Anesthesiologists (ASA) physical status ≤ II * Patients with body mass index (BMI) of 25 to 35 kg/m² * Unilateral inguinal hernia
Exclusion criteria
* Age \< 21 years * ASA physical status \> II * Patients with body mass index (BMI) \> 35 kg/m² * Pregnant women * Bilateral inguinal hernia * Large inguinoscrotal hernia * Incarcerated hernia * Recurrent hernia * Strangulated hernia * Prostatic diseases * History of; Convulsions, Cerebrovascular accident, Previous neurological diseases * Dysrhythmia * Hypertension * Ischemic heart disease * Hyperthyroidism * Liver or Renal impairment * Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] | 7 days after the end of the operation | NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days) |
| Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) | 7 days after the end of the operation | NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Operative duration (minutes) (mean±SD) | 2 minutes after the end of the operation | Time from skin incision till skin closure |
| Mean and Standard deviation of Length of hospital stay (hours) (mean±SD) | 24 hours after the end of the operation | Time from hospital admission till discharge |
| Number of participants and Rate of Intraoperative complications | 2 minutes after the end of the operation | Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury. |
| Number of participants and Rate of Postoperative complications | 1 year after the end of the operation | Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence. |
Countries
Egypt
Outcome results
None listed