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Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation

S

Suez Canal University

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: Fibrin glue fixation
Procedure: Tack fixation

Study type

Observational

Funder types

Other

Identifiers

NCT06679504
#4846/2022

Details and patient eligibility

About

The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.

Full description

A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).

Mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.

Furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age group of 18-60 years.
  2. All types of inguinal hernias.
  3. Didn't undergo pervious hernia repair surgery.

Exclusion criteria

  1. Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.
  2. Presence of other groin or abdominal hernias.
  3. Patients with complicated hernias such as irreducibility, obstruction, and incarceration.
  4. Patients with obesity or morbid obesity BMI >= 35.

Trial design

80 participants in 2 patient groups

Fibrin glue group
Description:
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue
Treatment:
Procedure: Fibrin glue fixation
Tack fixation group
Description:
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
Treatment:
Procedure: Tack fixation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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