MedPath

Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Number of participants and Rate of Postoperative complications1 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 complications2 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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.