MESH MIGRATION IN TOTAL EXTRAPERITONEAL INGUINAL HERNI REPAIR

NCT05655988 | Unknown DMC

• 1 other identifier: ANILLERGİNNN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal henri repair is among the most common operations performed by general surgery. The use of laparoscopy in inguinal hernia repair is becoming more common day by day. Laparoscopic inguinal hernia repair is being applied with increasing frequency due to its advantages such as reducing postoperative pain, providing early return to work and increasing patient satisfaction. Due to the widespread use of laparoscopic inguinal hernia repair, the best fixation method for the patches has become an increasingly questionable subject. It is thought that fixation of the patch with staples or clips may reduce the slippage of the patch, thus reducing the risk of hernia recurrence. In addition, it has been stated that the use of these fixation materials will both increase the cost and cause acute and chronic pain after surgery. In some studies in the literature, it was determined that not detecting the patch in laparoscopic inguinal hernia repair did not increase the recurrence. There are some studies showing that failure to fix the patch causes patch slippage in unilateral laparoscopic inguinal hernia repair. In this study, it was planned to investigate the rate of displacement of the patches fixed with staples in patches that do not require fixation in laparoscopic inguinal hernia repair surgeries, compared to the ones that were not fixed, and whether they cause recurrence. At the same time, whether the staples used for patch fixation increase postoperative pain will be evaluated with VAS (visual analog scale) at the postoperative 1st day, 1st month and 6th month after the operation, compared to the group without stapler patch fixation.

Conditions

Inguinal Hernia

Keywords

inguinal hernia; total extraperitoneal hernia repair; mesh migration; laparoscopic inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• mesh migration

  Deciding whether these meshes really require detection based on the extent of migration in non-detection meshes.

  1 year

Study Arms (2)

mesh migration after TEPP / fixation free mesh

ACTIVE COMPARATOR

After a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.

Diagnostic Test: inguinal ultrasonography

mesh migration after TEPP / mesh with fixation

ACTIVE COMPARATOR

TEPP surgeries performed with mesh fixation

Diagnostic Test: inguinal ultrasonography

Interventions

inguinal ultrasonography DIAGNOSTIC_TEST

After a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.

mesh migration after TEPP / fixation free mesh; mesh migration after TEPP / mesh with fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years. patients who have not had previous inguinal region surgery. Patients with a direct and/or indirect hernia smaller than 5 cm.

You may not qualify if:

• Complicated hernias. Patients undergoing mesh fixation for any reason. Patients with hemorrhage greater than 200 cc during or after surgery. Patients with drains. Patients with complications such as bleeding, early recurrence, wound infection in the early postoperative period.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

ANIL ERGİN

CONTACT

+905342245364; dranilergin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient, the paramedic providing post-operative care, and the radiologist measuring the mesh migration will not know whether mesh fixation has been applied to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uzman Doktor

Model Details: After a total extraperitoneal inguinal hernia operation performed using a fixation-free mesh, ultrasonography will be performed on all patients to calculate the slip size of the mesh.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: December 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 15, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

TU (1)