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

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 Overview

• Status: Completed
• Conditions: Inguinal Hernia Unilateral
• Intervention / Treatment: Other: Titanium tacker; Other: Polypropylene 0

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Beheira
    • Damanhūr, El-Beheira, Egypt
      • Damanhour Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Titanium tacker group (n=30); Group A	Other: Titanium tacker; Mesh fixation with Titanium tacker
Active Comparator: Polypropylene group (n=30); Group B	Other: Polypropylene 0; Mesh was sutured and fixed with polypropylene 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	7 days after the end of the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and Standard deviation of Operative duration (minutes) (mean±SD)	Time from skin incision till skin closure	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	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.	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.	1 year after the end of the operation

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Inguinal hernia; Mesh fixation; Titanium tacker
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: DTH: 22002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No