Hernia repair using a laparoscopic approach without traditional anesthesia methods

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

This study is testing a new way to fix inguinal hernias using a less invasive method without traditional anesthesia to see if it can reduce complications and still work well for patients.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elsan (other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT05323552 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of performing laparoscopic inguinal hernia repair using the totally extraperitoneal (TEP) approach without the use of curare and orotracheal intubation, instead utilizing a laryngeal mask airway for ventilation. The intervention aims to reduce complications associated with traditional anesthesia methods while maintaining effective surgical outcomes. The study is observational and will assess patients undergoing this innovative technique in an ambulatory surgical setting. The approach is particularly relevant given the recent global shortage of curares and the potential for allergic reactions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over with a non-recurrent unilateral inguinal hernia and a BMI below 30.

Not a fit: Patients who may not benefit include those unable to use a laryngeal mask airway or those who are pregnant or breastfeeding.

Why it matters

Potential benefit: If successful, this approach could enhance patient safety and comfort during hernia repair surgeries.

How similar studies have performed: While the use of laryngeal mask airways in similar procedures has been explored, this specific approach without curare is relatively novel.

Eligibility criteria

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

Where this trial is running

Nîmes

• Nouvel Hôpital Privé Les Franciscaines — Nîmes, France (RECRUITING)

Study contacts

• Principal investigator: David Amielh, MD — Nouvel Hôpital Privé Les Franciscaines, Nîmes
• Study coordinator: David Amielh, MD

Conditions: Hernia, Inguinal