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临床试验/NCT04504461
NCT04504461已完成不适用

Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Minimization Analysis in a South American Hospital

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1
主要终点
Incidence of surgical Complications

研究概览

简要总结

Laparoscopic inguinal hernia repair has become one of the elective techniques, attributing the advantages of minimally invasive procedures to it. However, the high costs related to the need for hospitalization and materials make them a limitation at the time of its indication.

The objective is to evaluate the feasibility of performing this procedure in an outpatient surgery center and the cost analysis of an outpatient procedure regarding the same in the setting of hospitalization.

详细描述

A retrospective analysis was performed on a prospective database in which all patients older than 18 years were included, in which a laparoscopic inguinal hernioplasty was performed in the period between August 2015 and June 2018 in the unit of ambulatory surgery of the Hospital Italiano de Buenos Aires. The same corresponds to an autonomous unit controlled by a health facility with hospitalization, as established by the Asociación Argentina de Cirugía in the Organization Guide and procedures in Ambulatory Surgery.

Laparoscopic repair using a transabdominal preperitoneal technique (TAPP) was proposed for patients with a clinical diagnosis of bilateral inguinal hernia or a recurrent unilateral hernia operated primarily through the anterior approach following the indications for laparoscopic surgery proposed by the European Hernia Society

The demographic data of the patients considered for this study were: age, gender, body mass index (BMI), anesthetic risk according to ASA (American Society of Anesthesiologists) score, comorbidities, bilateral primary or unilateral recurrent hernia, history of previous abdominal surgeries and associated midline hernias The details of the surgical procedure and the ambulatory surgery regimen, as well as possible postoperative complications, were explained to all patients in the preoperative consultation and an informed consent was signed.

The anesthetic technique was the same for everyone. The patients were operated under general anesthesia. Anesthetic induction was performed with propofol 2 mg / kg EV and fentanyl 2 ug / kg EV. Rocuronium 0.6 mg / kg EV was used to facilitate laryngeal mask placement. The anesthetic level was maintained with air, oxygen, sevoflorane at 1.5% expired and with remifentanil (0.25 at 0.5 ug / kg / min) based on the demand of the patient's plan. It was ventilated mechanically in controlled mode. As intraoperative analgesia, ketorolac 1 mg / kg according to renal function or diclofenac 1 mg / kg was used in patients with a history of bronchospasm. This was associated with 8 mg of dexamethasone. Antibiotic prophylaxis during anesthetic induction was performed with cefazolin 2 gr / kg EV.

In 100% of the cases, the surgical technique used was TAPP. The patient was asked to urinate prior to the transfer to the operating room to avoid the placement of a urinary catheter.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years old
  • Laparoscopic inguinal hernioplasty as the pincipal surgery

排除标准

  • Patients with, high anesthetic risk (decompensated ASA III and ASA IV)
  • Morbid obesity (higher BMI 40),
  • Sleep apnea with indication of use of CPAP (Continuous Positive Airway Pressure)
  • Medicated psychiatric disease,
  • Drug-dependent patient
  • Patients with an inadequate social environment-

结局指标

主要结局

Incidence of surgical Complications

时间窗: Patients follow up is 12 month

Incidence of seroma, Incidence of hematoma, % of reoperation, incidence of wound infection

Costs of the procedure

时间窗: One month after surgery

Cost of laparoscopic hernioplasty in ambulatory surgery center. Cost of laparoscopic hernioplasty when required hospital stay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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