Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.
NCT ID: NCT05323552
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
60 participants
OBSERVATIONAL
2022-11-21
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
NCT05504122
Laparscopic Hernioplasty in Recurrent Inguinal Hernia
NCT06050538
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
NCT03566433
Laparoscopic Inguinal Hernia Repair TEP vs TAPP
NCT07108972
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
NCT04114344
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Impossibility of using a laryngeal mask airway
3. Pregnant or breastfeeding woman
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elsan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Amielh, MD
Role: PRINCIPAL_INVESTIGATOR
Nouvel Hôpital Privé Les Franciscaines, Nîmes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nouvel Hôpital Privé Les Franciscaines
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-A02830-41
Identifier Type: OTHER
Identifier Source: secondary_id
FREE CURARE TEP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.