RecruitingNCT05323552

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

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

Sponsor

Elsan

Enrollment

60 participants

Start Date

Nov 21, 2022

Study Type

OBSERVATIONAL

Conditions

Hernia, Inguinal

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether laparoscopic (keyhole) hernia repair using the TEP (totally extraperitoneal) technique can be safely performed without general anesthesia — specifically without muscle relaxants (curare) and without a breathing tube (orotracheal intubation). The goal is to reduce anesthesia-related side effects and speed up recovery. You may be eligible if... - You are 18 or older - Your BMI is below 30 - You have a non-recurrent unilateral (one-sided) hernia - Your surgery is expected to take less than 60 minutes - You are suitable for day-surgery (ambulatory) as determined by your surgeon and anesthesiologist - You are informed and willing to participate You may NOT be eligible if... - You are under legal protection - A laryngeal mask airway (a type of breathing device) cannot be used for you - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic 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)