Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- immediate postoperative recovery
研究概览
简要总结
Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's recovery. Currently, minimally invasive surgical procedures combined with multimodal analgesia are commonly used to increase the quality of postoperative period.
Purpose To demonstrate that a minimally invasive approach including low insufflation pressure and minitrocars in laparoscopic hysterectomy improves postoperative recovery and reduces pain stimulation and opioid consumption in comparison with a conventional approach.
Methods After informed consent, all patients scheduled for a laparoscopic hysterectomy including those with carcinologic disease will be part of this monocentric prospective randomized double-blinded study.
At admission in our outpatient unit, patients will have to fill the Post-operative Quality of Recovery Scale assessment form, before to be randomized into one of the following two groups:
- Conventional approach: laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation pressures between 10 and 12 mmHg.
- Mini-invasive approach : laparoscopic surgery using mini-trocars (3 trocars of 3 mm and a 5 mm-optic trocar) with insufflation pressures of less than 8 mmHg.
Both groups will have general anesthesia with a deep neuromuscular blockade (TOF = 0 at the thumb adductor) and will benefit of our enhanced recovery program. Patients and evaluators will be blind regarding the allocated group.
The primary outcome is a comparison of the postoperative recovery between the two groups through the Post-operative Quality of Recovery Scale.This evaluation will include pain data, nausea/vomiting evaluation and cognitive function 6 hours after surgery.
Secondary outcomes are morphine consumption surgical comfort and patient satisfaction.
详细描述
Introduction About 43,000 hysterectomies were performed in France in 2016 half of them as a laparoscopic procedure. Compared to vaginal hysterectomy, laparoscopic surgery decreases postoperative pain and hospital length of stay [PubMed ID: 25524534 ]. Laparoscopic hysterectomy is also the most common surgical technique in the USA within enhanced recovery after surgery programs (ERAS)[2]. However, postoperative pain is still an important issue and results in most of the early re-admissions [3]. In addition, control of intraoperative stress, including painful stimuli, but also endocrine-metabolic and inflammatory responses is a major component of patient's recovery improvement. Reducing length of stay can lead to a possible outpatient surgery with a high level of quality and safety.
Hysterectomy in outpatient setting is barely done in France (0.1% in 2012 and 1.5% in 2017) compare to USA (more than 50%) so there is still a significant scope of improvement [2].
Many parameters need to be controlled to reduce perioperative stress [4,5]. Francophone teams showed that the use of mini-invasive techniques such as low and stable abdominal insufflation pressure is an important factor regarding pain and inflammation after gynecological surgery [6,7]. Furthermore to reduce parietal and peritoneal injuries can be achieved by using very small trocars while allowing surgery to be performed in good conditions [8,9]. Some teams have combined these two techniques with promising results in abdominal surgery [10].
The choice of anesthesia technic within an ERAS program that include quick elimination drugs, vascular filling monitoring and optimization, prevention of hypothermia and postoperative nausea/vomiting (PONV), as well as a multimodal analgesia, including loco-regional analgesia allow a faster postoperative recovery after pelvic surgery [11, 12]. Among these parameters, post-operative pain management is a major component. It has been demonstrated that pain prolongs surgical stress, delays mobilization and full recovery. Opioid medication therapy results in many adverse effects (PONV, sedation) and delays postoperative recovery[12]. Furthermore, availability of opioids at home is currently a real public health issue[13]. After a conventional hysterectomy use of opioids is almost systematic[14]. Therefore the challenge is to provide effective analgesia with the minimum of opioids use. Anesthesia with a deep neuromuscular blockade allows a low peritoneal pressure while maintaining optimal surgical comfort[15].
Hypothesis A mini-invasive approach of laparoscopic hysterectomy, combining mini-trocars and low pneumoperitoneum pressure would improve quality of post-operative recovery and reduce length of stay in the hospital allowing the procedure to be performed as outpatient surgery.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •programmed to laparoscopic hysterectomy
- •stable ASA score <3
- •no contraindication to take nonsteroidal anti-inflammatory drugs
- •absence of chronic pain
- •perfect understanding of post-operative psycho-motor assessment
- •presence of an attendant
- •distance between home and hospital allowing a possible quick readmission
- •acceptance to respect all the given medical instructions.
排除标准
- •laparo-conversion and surgical or anesthetic complication.
结局指标
主要结局
immediate postoperative recovery
时间窗: 6th post-operative hour
determined by the Post Operative Quality of recovery scale PQRS (pain score, PONV and cognitive recovery)
次要结局
- Surgical comfort(6th post-operative hour)
- rate of return after discharge(Day 7 after discharge)
- Incidence of PONV(2nd, 6th and 24th post-operatives hours)
- Patient satisfaction: EVAN G score(24th post-operative hour)
- Bowel movement(Day 1 after discharge)
- PADSS scores(2nd and 6th post-operatives hours)
- intraoperative intensity of nociceptive stimulation(4th induction hour)
- postoperative pain intensity: Verbal Numeric Scale (VNS)(2nd, 6th and 24th post-operatives hours)
- Number of outpatients(Day 1 after discharge)
- intravenous morphine consumption(2nd, 6th and 24th post-operatives hours)
- Surgery duration, length of stay in PACU(4th post-operative hour)