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

E

Elsan

Status

Enrolling

Conditions

Hernia, Inguinal

Treatments

Procedure: Laparoscopic TEP hernia repair without curare and without orotracheal intubation.

Study type

Observational

Funder types

Other

Identifiers

NCT05323552
FREE CURARE TEP
2021-A02830-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female aged 18 or over
  2. BMI below 30
  3. Non-recurrent unilateral hernia
  4. Operating time estimated at less than 60 minutes at the surgeon's discretion
  5. Patients eligible to an ambulatory surgical setting at the discretion of the surgeon and the anesthetist
  6. Patient informed of the study and agreed to take part.

Exclusion criteria

  1. Patient under legal protection measures
  2. Impossibility of using a laryngeal mask airway
  3. Pregnant or breastfeeding woman

Trial design

60 participants in 1 patient group

Hernia repair with laparoscopic TEP approach without curare and without orotracheal intubation.
Description:
Patients will undergo laparsocopic TEP hernia repair without curare and without orotracheal intubation.
Treatment:
Procedure: Laparoscopic TEP hernia repair without curare and without orotracheal intubation.

Trial contacts and locations

1

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Central trial contact

David Amielh, MD

Data sourced from clinicaltrials.gov

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