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

NCT05323552 | Recruiting

• 2 other identifiers: FREE CURARE TEP2021-A02830-41
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of the intervention-related ambulatory surgical setting failure.

  During the procedure

• Assessment of the procedure change rate, from a TEP approach to a Trans-Abdominal Pre-Peritoneal approach (TAPP).

  During the procedure

• Evaluation of the occurrence of post-operative complications during the first month following the intervention.

  At 1 month after the procedure

• Pain assessment

  After the procedure and the day after the intervention by phone call

Study Arms (1)

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.

Interventions

Laparoscopic TEP hernia repair without curare and without orotracheal intubation. PROCEDURE

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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Nouvel Hôpital Privé Les Franciscaines

Nîmes, 30000, France

RECRUITING

Related Publications (9)

• 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.

  BACKGROUND

• 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.

  PMID: 23702873 BACKGROUND

• 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.

  PMID: 17353992 BACKGROUND

• Baillard C, Bourgain JL, Bouroche G, et al. Actualisations de recommandations - Curarisation et décurarisation en anesthésie. Société Française d'Anesthésie et de Réanimation, 2018.

  BACKGROUND

• 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.

  PMID: 23702866 RESULT

• 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.

  PMID: 23538536 RESULT

• 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.

  PMID: 23572220 RESULT

• 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.

  PMID: 15107485 RESULT

• 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.

  PMID: 12549684 RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Curare

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• David Amielh, MD

  Nouvel Hôpital Privé Les Franciscaines, Nîmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Amielh, MD

CONTACT

04 66 38 97 67; davidamielh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: November 21, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (1)