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

NCT05323552 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

  • Hernia, Inguinal

Interventions

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)

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • David Amielh, MD · Nouvel Hôpital Privé Les Franciscaines, Nîmes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323552 on ClinicalTrials.gov