A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- length of hospitalisation
研究概览
简要总结
Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program
详细描述
Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track recovery program group compared to conventional recovery group.
The pimary outcome is time to discharge from the end of operation to discharge.
The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding, operative time, postoperative complications, the cost of the laparoscopic 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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •uterine size less than uterine size at 14 weeks of pregnancy
- •at list one friend or family available to care to care after discharge.
- •Exclusion criteria:
- •endometriosis
- •contraindications to any of medications used in the study (oxycodone, ketoprofen, or paracetamol)
- •language difficulties (inability to understand and speak Finnish or Swedish)
- •age older that 70 years
- •mental health disability that limit autonomy
排除标准
- 未提供
研究组 & 干预措施
fast-track recovery program
Pre-operative Verbal and video information Tobacco cessation Daily physical activity Light meal 6 hours and clear liquids up to 2 hours before surgery No bowel preparation A warm blanket Premedication paracetamol 1g and tematsepam 20mg
Intraoperatively For nausea and voimiting dexamethasone 10mg, dehydrobensperidol 1mg and ondancetron 4mg before emergence Analgesia: ropivacain at port sites before incision and at vaginal vault Opioids intravenously at discretion of anesthesiologist supplemented with Dexketoprofen 50mg Urinary catheter early removal Postoperative Pain: tramadol 50mg and ketoprofen100mg i.v., oral opioid if needed; patients with normal pain control receive oral pregabalin 25mg every 8 hours, paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours until discharge Out of bed after 2 hours from the end of surgery A liquid diet, if tolerated regular normal diet. For emesis ondansetron 4mg
干预措施: fast-track recovery program (Procedure)
conventional recovery program
Preoperative preparation Verbal and written information Cessation of oral intake after previous midnight. Premedication paracetamol 1g+ diatsepam 5mg.
Intraoperative A warm blanket at the start of procedure. Prophylaxis for nausea and vomiting: Dexamethasone 5mg at induction, and Dehydrobenzperidol 1mg, ondancetron 4mg before emergence. Analgesia: injection of ropivacain 5% 20ml at port sites at the end of surgery, Opioids i.v. (oxycodone)
Postoperative Pain medication:Opioids i.v. (oxycodone), paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours Urinary catheter removal on next morning. Prolonged bowel and bed rest and gradual reintroduction of feeding.
结局指标
主要结局
length of hospitalisation
时间窗: up to one week
time from end of operation until discharge
次要结局
- postoperative pain score(change in 24 hours after surgery)
- vomiting(change in 24 hours after surgery)
- nausea(change in 24 hours after surgery)
- Patient subjective psychological stress level by general health questionnaire(GHQ12)(1 month before the surgery, in the morning of surgery day and one month after surgery)
- patient quality of life(1 month before the surgery, in the morning of surgery day and one month after surgery)
- complications(Up to one week.)
- The use of anelgesics for posoperative pain.(change in 24 hours after surgery)
- Patient quality of life(1 month before the surgery, in the morning of surgery day and one month after surgery)
研究者
Päivi Päkarinen
MD PhD Specialist on gynecologic oncology,senior consultant, gynecologic onkology
Helsinki University Central Hospital