Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
- Conditions
- Inguinal Hernia Unilateral
- Registration Number
- NCT05574751
- Lead Sponsor
- Damanhour Teaching Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Damanhour Teaching Hospital
🇪🇬Damanhūr, El-Beheira, Egypt
Damanhour Teaching Hospital🇪🇬Damanhūr, El-Beheira, Egypt