Prospective Study Assessing the Laparoscopic Totally ExtraPeritoneal (TEP) Hernia Repair Without Curare and Without Orotracheal Intubation (Free Curare TEP Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of the number of laparoscopic TEP hernia repairs carried out under optimal conditions compared to an intervention requiring adaptation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient under legal protection measures
- •Impossibility of using a laryngeal mask airway
- •Pregnant or breastfeeding woman
结局指标
主要结局
Comparison of the number of laparoscopic TEP hernia repairs carried out under optimal conditions compared to an intervention requiring adaptation.
时间窗: During the procedure
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.
次要结局
- Assessment of the intervention-related ambulatory surgical setting failure.(During the procedure)
- Pain assessment(After the procedure and the day after the intervention by phone call)
- 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)