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

NCT ID: NCT05574751

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-11-01

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.

Conditions

Inguinal Hernia Unilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Titanium tacker group (n=30)

Group A

Group Type: ACTIVE_COMPARATOR

Titanium tacker

Intervention Type: OTHER

Mesh fixation with Titanium tacker

Polypropylene group (n=30)

Group B

Group Type: ACTIVE_COMPARATOR

Polypropylene 0

Intervention Type: OTHER

Mesh was sutured and fixed with polypropylene 0

Interventions

Titanium tacker

Mesh fixation with Titanium tacker

Intervention Type: OTHER

Polypropylene 0

Mesh was sutured and fixed with polypropylene 0

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Countries

Egypt

Other Identifiers

DTH: 22002

Identifier Type: -

Identifier Source: org_study_id