Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- success rate of ambulatory care
研究概览
简要总结
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.
The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.
The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.
The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.
The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18 years
- •planned surgery procedure : ambulatory laparoscopic hysterectomy
- •effective contraception if women of childbearing age
- •patients with free, informed and signed consent
排除标准
- •disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- •pregnancy or wish for subsequent pregnancy
- •lactating women
- •contraindication to laparoscopy
- •contraindication to minimally invasive endoscopic techniques
- •not eligible for outpatient care
- •inability to understand the information given
- •a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
研究组 & 干预措施
Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
干预措施: Low Impact Laparoscopy (Device)
Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
干预措施: Visual Analog Scale (VAS) for Pain (Other)
Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
干预措施: Saint-Antoine Pain Questionnaire (QDSA) (Other)
Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
干预措施: post-operative questionnaire (Other)
conventional laparoscopy
conventional laparoscopy
干预措施: conventional laparoscopy (Device)
conventional laparoscopy
conventional laparoscopy
干预措施: Visual Analog Scale (VAS) for Pain (Other)
conventional laparoscopy
conventional laparoscopy
干预措施: Saint-Antoine Pain Questionnaire (QDSA) (Other)
conventional laparoscopy
conventional laparoscopy
干预措施: post-operative questionnaire (Other)
结局指标
主要结局
success rate of ambulatory care
时间窗: 1 month after surgery
rate of patients actually managed on an outpatient setting (discharged from hospital the same day of the intervention) and who presented no complication or rehospitalization in the month following the intervention
次要结局
- pain score (VAS)(1 month after surgery)
- number of patients who needed an analgesic(1 month after surgery)
- number of days of work stoppage(1 month after surgery)
- pain score (Saint-Antoine Pain Questionnaire (QDSA))(the day after surgery)
- dose of morphine(at the exit of a post-interventional surveillance room, an average of 2 hours after arrival)
- total administered dose(1 month after surgery)
- duration of analgesic treatment(1 month after surgery)
- types of per and postoperative complications(1 month after surgery)
- pain score (Visual analogic scale (VAS) for pain)(arrival in the post-interventional surveillance room)
- pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire))(6 hours after exit of operating room)
- operating time(at the exit of the operating room, an average of 30 minutes after surgery)
- number of per and postoperative complications(1 month after surgery)
- number of days of hospital stay(on leaving the hospital)
- hours total of stay in the post-intervention monitoring room(at the exit of a post-interventional surveillance room)
- patient management costs(1 month after surgery)
- pain score (VAS)(30 minutes after exit of operating room)
- pain score (VAS)(2 hours after exit of operating room)
- pain score (VAS)(4 hours after exit of operating room)
- pain score (VAS)(6 hours after exit of operating room)
- pain score (VAS)(at the exit of a post-interventional surveillance room, an average of 2 hours after arrival)
- pain score (VAS)(on leaving the hospital, an average of 8 hours after surgery)
- pain score (VAS)(the day after surgery)
- number of patients who needed an analgesic(at the exit of a post-interventional surveillance room, an average of 2 hours after arrival)
- number of patients who needed an analgesic(on leaving the hospital, an average of 8 hours after surgery)
- total administered dose(at the exit of a post-interventional surveillance room, an average of 2 hours after arrival)
- total administered dose(on leaving the hospital, an average of 8 hours after surgery)
- duration of analgesic treatment(on leaving the hospital)