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Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

NCT05152654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-10

No results posted yet for this study

Summary

Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it

Conditions

  • Inguinal Hernia
  • Pain, Acute
  • Pain, Chronic

Interventions

DEVICE

Tacker

metallic staples used to fix the mesh

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Principal Investigators

  • Murat B YILDIRIM · Hitit University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-31
Completion
2021-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152654 on ClinicalTrials.gov