An observational study in Hernia, Inguinal, sponsored by Elsan. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Elsan · Observational
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.
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →Elsan is the lead sponsor of 66 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that will undergo a laparoscopic TEP hernia repair without curare and without orotracheal intubation, eligible to an ambulatory surgical setting.
Exclusion Criteria:
Patients will undergo laparsocopic TEP hernia repair without curare and without orotracheal intubation.
Procedure: Laparoscopic TEP hernia repair without curare and without orotracheal intubation.
All the techniques and protocols used for this monocentric study are standardized: * The anesthesia is general, the anesthetic products administered are identical, * ventilation is ensured by the use of a laryngeal mask airway, without curare administered * the surgery is an extraperitoneal laparoscopy with an optical trocar under the umbilical and two operators with the placement of a preformed type 3G polypropylene prosthesis * the analgesic protocol is free of opioids (Opioid Free Anesthesia - OFA)
Comparison of the number of laparoscopic TEP hernia repairs carried out under optimal conditions compared to an intervention requiring adaptation.
The intervention will be qualified as successful if the following three criteria (i.e. optimal conditions) are validated: * No use of curares AND * Use of a laryngeal mask airway for the entire duration of the procedure (no use of orotracheal intubation) AND * Ambulatory surgical setting, or hospital setting only if not related to the intervention (e.g.: organizational problem of returning home). If one of the above criteria is not met, the intervention will be considered as failure for the primary endpoint.
Time frame: During the procedure
Assessment of the intervention-related ambulatory surgical setting failure.
Comparison of the proportions of ambulatory surgical settings versus inpatient hospitalizations.
Time frame: During the procedure
Assessment of the procedure change rate, from a TEP approach to a Trans-Abdominal Pre-Peritoneal approach (TAPP).
Comparison of the proportions between the TEP approach and the TAPP approach.
Time frame: During the procedure
Evaluation of the occurrence of post-operative complications during the first month following the intervention.
Collection of Adverse Events until the follow-up visit at 1 month.
Time frame: At 1 month after the procedure
Pain assessment
Pain assessment by a Visual Analogue Scale (VAS) before returning home and then during the phone call the day after the intervention.
Time frame: After the procedure and the day after the intervention by phone call
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