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

NCT06679504 | Completed

• 1 other identifier: #4846/2022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain assessment

  7 days, 15 days, 1 month, 2 months, and 3 months.

Study Arms (2)

Fibrin glue group

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue

Procedure: Fibrin glue fixation

Tack fixation group

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

Procedure: Tack fixation

Interventions

Fibrin glue fixation PROCEDURE

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation

Fibrin glue group

Tack fixation PROCEDURE

Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation

Tack fixation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameh Tolba, PhD, MD

  Suez canal University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and lecturer of Surgery

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: July 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: June 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

EG (1)