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

NCT ID: NCT06679504

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-06-30

Brief Summary

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.

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

Conditions

Inguinal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fibrin glue group

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue

Fibrin glue fixation

Intervention Type: PROCEDURE

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

Tack fixation

Intervention Type: PROCEDURE

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation

Interventions

Fibrin glue fixation

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation

Intervention Type: PROCEDURE

Tack fixation

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Waleed Ghareeb

Consultant and lecturer of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Tolba, PhD, MD

Role: STUDY_DIRECTOR

Suez canal University Hospital

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

#4846/2022

Identifier Type: -

Identifier Source: org_study_id