Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation. — FREE_CURARE  

Hernia, Inguinal Clinical Trial

Official title: Prospective Study Assessing the Laparoscopic Totally ExtraPeritoneal (TEP) Hernia Repair Without Curare and Without Orotracheal Intubation (Free Curare TEP Study).

Status Recruiting

Clinical Trial Summary

Laparoscopic treatment of inguinal hernia with the totally extraperitoneal approach (TEP) is indicated for simple and bilateral inguinal hernias. It consists of placing a large prosthesis in the posterior position by direct access to the extra-peritoneal space. This prosthesis is interposed between the defective wall and the peritoneum. Unlike the transperitoneal laparoscopic method, the strictly extraperitoneal approach reduces complications related to contact with the intestinal loops and preserves the peritoneal layer intact.

TEP approach is traditionally performed under general anesthesia with curare and orotracheal intubation.

In the study, we would like to assess this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation.

Clinical Trial Description

Laparoscopic TEP hernia repair is traditionally performed under general anesthesia with curare and orotracheal intubation. Indeed, according to the French SFAR Recommendations (2018) regarding to curarization and decurarization in anesthesia, it is recommended to administer a curare to facilitate intubation of the trachea. Moreover, the SFAR in these same recommendations specifies that it is probably not recommended to systematically administer curare to facilitate the fitting of a supraglottic airway device (otherwise called a laryngeal mask airway).

The idea of this study is to perform this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation. This ventilation technique has already been commonly used by the site for several years. The recent global shortage of curares has led them to increasingly resort to this method during this phase of the global pandemic.

In addition, limiting the patients exposure to curares avoids possible anaphylactic reactions. According to the SFAR, the incidence of anaphylactic reactions to curares varies by country. It was estimated at 184.0 [139.3 - 229.7] in France, 250.9 [189.8 - 312.9] for women and 105.5 [79.7 - 132.0] for men.

The main hypothesis of the study is that the repair of inguinal hernia using the totally extraperitoneal laparoscopic approach (TEP) is feasible without curares and without orotracheal intubation. ;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

• NCT number: NCT05323552
• Study type: Observational
• Source: Elsan
• Contact: David Amielh, MD
• Phone: 04 66 38 97 67
• Email: davidamielh@gmail.com
• Status: Recruiting
• Start date: November 21, 2022
• Completion date: June 2024