Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair; Prospective Randomized Double-blinded Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Pain, Acute; Pain, Chronic
• Intervention / Treatment: Device: Tacker

Detailed Description

The study will be conducted as a prospective, double-blind, randomized controlled study in the general surgery clinic of a university hospital. As a result of the power analysis calculated under Cohen's expert opinion, it was decided to include a total of 100 patients, 50 patients in order to reach 80% power with 0.50 effect size (medium effect) and 5% error (alpha=0.05). in each group. The study will continue by taking the consent of the patients and choosing from among the volunteer patients. The method by which the patients will be operated will be determined by choosing from a total of 100 (50 per group) sealed envelopes containing the group names. In the first (Fixation Group) group, inguinal hernia repair with the TEP method will be fixed with a mesh stapler. While inguinal hernia repair is performed with TEP method in the second (Non-Fixation Group) group, the mesh will not be fixed by any method. Exclusion criteria; It was determined as being younger than 18 years of age, having a comorbidity that prevented him from receiving general anesthesia, having had a previous lower abdominal surgery, having undergone previous inguinal hernia surgery, having bilateral inguinal hernia, scrotal hernia or strangulated hernia.

Creation of double blind; Patients will not be told which study group participants are in as a result of the envelope participants choose. In the postoperative follow-up of the patients, the researcher who recorded the parameters related to the study and provided the measurements will not know which group the patients are in.

Age, gender, comorbidity, smoking history and body mass index of the patients will be recorded on the preoperative forms. The surgery will be performed by a single surgeon according to the group chosen by the patients. The performing surgeon was a general surgeon with 5 years of active experience in laparoscopic hernia surgery and had performed both methods more than 200 times. Until the end of the study, only the surgeon will know which group the patients are in. The investigator evaluating the results of the study and the performing surgeon will not communicate about the study.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çorum, Turkey, 19030
    • Hitit University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Fixation; 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.
EXPERIMENTAL: Non-Fixation; 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; metallic staples used to fix the mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hitit University
• Investigators: Principal Investigator: Murat B YILDIRIM, Hitit University

Publications and helpful links

General Publications

• 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.
• 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
• 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. 2022 Mar 14. doi: 10.1007/s10029-022-02587-w. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (ACTUAL): December 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Acute Pain
• Other Study ID Numbers: Mesh fixation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No