Clinical trial NCT05574751: Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
Official title: Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia Unilateral
Keywords: Inguinal hernia
Mesh fixation
Titanium tacker
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
timeFrame: 7 days after the end of the operation
measure: Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
timeFrame: 7 days after the end of the operation
Secondary outcomes:
measure: Mean and Standard deviation of Operative duration (minutes) (mean±SD)
timeFrame: 2 minutes after the end of the operation
measure: Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)
timeFrame: 24 hours after the end of the operation
measure: Number of participants and Rate of Intraoperative complications
timeFrame: 2 minutes after the end of the operation
measure: Number of participants and Rate of Postoperative complications
timeFrame: 1 year after the end of the operation
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References: