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

Damanhour Teaching Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Inguinal Hernia Unilateral

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]

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)

Time frame: 7 days after the end of the operation

Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)

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)

Time frame: 7 days after the end of the operation

Secondary Outcomes

Mean and Standard deviation of Operative duration (minutes) (mean±SD)

Time from skin incision till skin closure

Time frame: 2 minutes after the end of the operation

Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)

Time from hospital admission till discharge

Time frame: 24 hours after the end of the operation

Number of participants and Rate of Intraoperative complications

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.

Time frame: 2 minutes after the end of the operation

Number of participants and Rate of Postoperative complications

Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.

Time frame: 1 year after the end of the operation