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

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

Inclusion Criteria6

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

Exclusion Criteria3

  • Patient under legal protection measures
  • Impossibility of using a laryngeal mask airway
  • Pregnant or breastfeeding woman

Interested in this trial?

Get notified about updates and connect with the research team.

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)


Locations(1)

Nouvel Hôpital Privé Les Franciscaines

Nîmes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05323552


Related Trials