Clinical trial NCT06679504: Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
Official title: Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients complain of uncomplicated inguinal hernia who are scheduled for laparoscopic TEP hernioplasty

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.

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.

Primary outcomes:
measure: Quality of life assessment
timeFrame: 7 days, 15 days, 1 month, 2 months, and 3 months.
Secondary outcomes:
measure: Postoperative pain assessment
timeFrame: 7 days, 15 days, 1 month, 2 months, and 3 months.
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez canal University Hospital
name: Sameh Tolba, PhD, MD
role: STUDY_DIRECTOR
References: