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

Inguinal Hernia Unilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574751
• Other study ID #: DTH: 22002
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2022
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Unilateral

Intervention

Other:
• Titanium tacker
Mesh fixation with Titanium tacker
• Polypropylene 0
Mesh was sutured and fixed with polypropylene 0

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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