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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Procedure: Laparoscopic TEP hernia repair without curare and without orotracheal intubation.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: David Amielh, MD; Phone Number: +33 04 66 38 97 67; Email: davidamielh@gmail.com

Study Locations

• France
  • Nîmes, France, 30000
    • Recruiting
    • Nouvel Hôpital Privé les Franciscaines
    • Contact: David Amielh, MD; Phone Number: +33 04 66 38 97 67; Email: davidamielh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that will undergo a laparoscopic TEP hernia repair without curare and without orotracheal intubation, eligible to an ambulatory surgical setting.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hernia repair with laparoscopic TEP approach without curare and without orotracheal intubation.; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the intervention-related ambulatory surgical setting failure.	Comparison of the proportions of ambulatory surgical settings versus inpatient hospitalizations.	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.	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.	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.	After the procedure and the day after the intervention by phone call

Collaborators and Investigators

• Sponsor: Elsan
• Investigators: Principal Investigator: David Amielh, MD, Nouvel Hôpital Privé Les Franciscaines, Nîmes

Publications and helpful links

General Publications

• Fitzgibbons RJ, Richards AT, Quinn TH. Open hernia repair. In: Souba WS, Mitchell P, Fink MP, Jurkovich GJ, Kaiser LR, Pearce WH, et al., editors. ACS surgery: principles and practice. 6th ed. Philadelphia, USA: Decker Publishing Inc.; 2002. p. 828-49.
• Meyer A, Dulucq JL, Mahajna A. Laparoscopic totally extraperitoneal hernioplasty with nonfixation of three-dimensional mesh: Dulucq's technique. Arq Bras Cir Dig. 2013 Jan-Mar;26(1):59-61. doi: 10.1590/s0102-67202013000100013. English, Portuguese.
• Miserez M, Alexandre JH, Campanelli G, Corcione F, Cuccurullo D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB. The European hernia society groin hernia classification: simple and easy to remember. Hernia. 2007 Apr;11(2):113-6. doi: 10.1007/s10029-007-0198-3. Epub 2007 Mar 13. Erratum In: Hernia. 2008 Jun;12(3):335.
• Baillard C, Bourgain JL, Bouroche G, et al. Actualisations de recommandations - Curarisation et décurarisation en anesthésie. Société Française d'Anesthésie et de Réanimation, 2018.
• Meyer A, Dulucq JL, Mahajna A. Laparoscopic hernia repair: nonfixation mesh is feasibly? Arq Bras Cir Dig. 2013 Jan-Mar;26(1):27-30. doi: 10.1590/s0102-67202013000100006. English, Portuguese.
• Meyer A, Blanc P, Balique JG, Kitamura M, Juan RT, Delacoste F, Atger J. Laparoscopic totally extraperitoneal inguinal hernia repair: twenty-seven serious complications after 4565 consecutive operations. Rev Col Bras Cir. 2013 Jan-Feb;40(1):32-6. doi: 10.1590/s0100-69912013000100006. English, Portuguese.
• Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.
• Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
• Ozgun H, Kurt MN, Kurt I, Cevikel MH. Comparison of local, spinal, and general anaesthesia for inguinal herniorrhaphy. Eur J Surg. 2002;168(8-9):455-9. doi: 10.1080/110241502321116442.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Curare
• Other Study ID Numbers: FREE CURARE TEP; 2021-A02830-41 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No