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

Quality of Life After 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, our study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Fibrin glue fixation; Procedure: Tack fixation

Detailed 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, our study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients complain of uncomplicated inguinal hernia who are scheduled for laparoscopic TEP hernioplasty

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibrin glue group; Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue	Procedure: Fibrin glue fixation; Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation
Tack fixation group; Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation	Procedure: Tack fixation; Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	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..	7 days, 15 days, 1 month, 2 months, and 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain assessment	VAS; visual analogue scale. for pain assessment	7 days, 15 days, 1 month, 2 months, and 3 months.

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: Sameh Tolba, PhD, MD, Suez Canal University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: #4846/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No