Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

NCT05152654 | Completed

• 1 other identifier: Mesh fixation
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• displacement of the mesh one day after surgery

  It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one day after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.

  one day after surgery

• displacement of the mesh one week after surgery

  It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one week after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.

  first week after surgery and 6th month after surgery

• displacement of the mesh six month after surgery

  It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken 6 months after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.

  first week after surgery and 6th month after surgery

• Postoperative 24th hours pain

  Patients will be asked about their visual pain score at the postoperative 24th hour. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)

  24th hours after surgery

• Postoperative 6th months pain

  Patients will be asked about their visual pain score at 6 months postoperatively. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)

  6th month after surgery

Study Arms (2)

Fixation

NO INTERVENTION

Total extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will be fixed to the hernia area by the non-absorbable tacker.This method is the method used routinely in the treatment of laparoscopic hernia today.

Non-Fixation

EXPERIMENTAL

Total extra peritoneal repair will be performed in this arm for the patients due to unilateral inguinal hernia. The 15x12 cm mesh will be marked with titanium clips from its 4 corners and placed in the hernia area. The mesh will not be detected in any way.

Device: Tacker

Interventions

Tacker DEVICE

metallic staples used to fix the mesh

Non-Fixation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being over 18 years old
• having a unilateral inguinal hernia

You may not qualify if:

• being under18 years old
• having comorbidity that prevents him from receiving general anesthesia
• having undergone previous lower abdominal surgery
• having previous surgery for inguinal hernia
• having bilateral inguinal hernia, scrotal hernia or strangulated hernia

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, 19030, Turkey (Türkiye)

Location

Related Publications (3)

• Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.

  PMID: 28214943 RESULT

• Darwish A. A, Hegab A. A . Tack fixation versus nonfixation of mesh in laparoscopic transabdominal preperitonaeal hernia repair. Egyptian Journal of Surgery. 2016;35(4): 327-331. DOI: 10.4103/1110-1121.194729

  RESULT

• Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14.

  PMID: 35286511 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Murat B YILDIRIM

  Hitit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Only the practicing surgeon will know which group the patients will be in until the end of the study. will not share this information with researchers and patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Patients participating in the study will be divided into two groups. Patients with unilateral inguinal hernia will be determined according to the envelope selection method. Patients will not know which group are in. The patients in the first group will be fixed with 5 tackers while performing total extraperitoneal repair. While the patients in the second group are performing total extraperitoneal repair, no fixation will be made while placing the mesh.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 10, 2021
• Study Start: December 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: August 31, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)