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Completed

NCT Number: NCT06679504

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fibrin glue fixation

Procedure

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation

Tack fixation

Procedure

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation

Primary outcomes

  1. Quality of life assessment

    Time frame: 7 days, 15 days, 1 month, 2 months, and 3 months.

    The postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..

Secondary outcomes

  1. Postoperative pain assessment

    Time frame: 7 days, 15 days, 1 month, 2 months, and 3 months.

    VAS; visual analogue scale. for pain assessment. the score ranges from 1-10... higher score denotes more pain.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Nov 12, 2024

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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