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Completed

NCT Number: NCT05574751

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.

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Key information

Conditions

Inguinal Hernia Unilateral Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titanium tacker

Other

Mesh fixation with Titanium tacker

Polypropylene 0

Other

Mesh was sutured and fixed with polypropylene 0

Primary outcomes

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

    Time frame: 7 days after the end of the operation

    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)

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

    Time frame: 7 days after the end of the operation

    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)

Secondary outcomes

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

    Time frame: 2 minutes after the end of the operation

    Time from skin incision till skin closure

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

    Time frame: 24 hours after the end of the operation

    Time from hospital admission till discharge

  3. Number of participants and Rate of Intraoperative complications

    Time frame: 2 minutes after the end of the operation

    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.

  4. Number of participants and Rate of Postoperative complications

    Time frame: 1 year after the end of the operation

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

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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