Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Bilateral Inguinal Hernia?

Pain Clinical Trial

Official title:

Prospective Randomized Study of Comparison Mesh Displacement in Bilateral Laparoscopic İnguinal Hernia Repair With No Fixation: eTEP Versus TEP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070207
• Other study ID #: 55555555555
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: Konya City Hospital
• Contact: Abdullah Hilmi Yilmaz, MD
• Phone: 0432 222 00 10
• Email: drabdullahhilmi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. These studies are generally planned for unilateral hernias. It is a controversial issue among surgeons that the possibility of mesh migration is higher in bilateral hernias since there is a larger dissection area. This discussion is the starting point of this study. There were no studies in the literature regarding mesh fixation in bilateral inguinal hernias. The aim of this study is to compare bilateral inguinal hernia patients with and without mesh fixation in the eTEP technique in terms of both mesh migration and clinical features.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with bilateral inguinal hernias.
• Patients aged 18-65.

Exclusion Criteria:

• Younger than 18 years, and older than 65 years
• Incarcerated or strangulated inguinal hernias,
• Recurrent hernias.
• Patients with unilateral inguinal hernias.
• Patients who are contraindicated to receive general anesthesia.
• Pregnancy

Related Conditions & MeSH terms

• Hernia, Inguinal
• Pain
• Postoperative Complications
• Relapse

Intervention

Procedure:
• TEP group
Inguinal hernia surgery will be performed with the TEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.
• eTEP group
Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.

Locations

Country	Name	City	State
Turkey	University of Health Science Van Training and Research Hospital	Van

Sponsors (2)

Lead Sponsor	Collaborator
Mehmet Esref Ulutas	Van Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Claus CM, Rocha GM, Campos AC, Bonin EA, Dimbarre D, Loureiro MP, Coelho JC. Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh. Surg Endosc. 2016 Mar;30(3):1134-40. doi: 10.1007/s00464-015-4314-7. Epub 2015 Jun 20. — View Citation

Claus CMP, Rocha GM, Campos ACL, Paulin JAN, Coelho JCU. Mesh Displacement After Bilateral Inguinal Hernia Repair With No Fixation. JSLS. 2017 Jul-Sep;21(3):e2017.00033. doi: 10.4293/JSLS.2017.00033. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of Mesh Displacement	Patients who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm.	postoperative 24 hours, 1 and 6 months
Secondary	Rate of Postoperative pain	It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.	postoperative 24 hours
Secondary	Rate of Hernia recurrence	hernia recurrence after six months of follow-up. It will be checked by physical examination. Imaging methods will be used in suspicious cases.	postoperative 6th month
Secondary	Rate of Postoperative complications	such as wound infection, bleeding	postoperative 24 hours and 1st month
Secondary	Rate of Chronic pain	It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.	postoperative 1st and 6th month