Evaluation of Modified Enhanced Recovery Program in Emergency Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Postoperative length of stay (pLOS)
研究概览
简要总结
Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost 10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS) program has proven its effectiveness in elective surgery and can theoretically improve outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to investigate the safety and efficacy of a modified ERAS protocol in LA.
详细描述
A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing, limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics; low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of stay (pLOS).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any stage of acute appendicitis except 3B according to Gomes classification;
- •Class I-II surgical patients according to the classification of The American Society of Anesthesiologists (ASA).
排除标准
- •Patient refusal to participate in the study or to sign the informed consent form;
- •Language barrier;
- •Transfer to the intensive care unit (ICU) after surgery;
- •ASA class ≥ III;
- •Conversion to open procedure;
- •Appendicular mass found during laparoscopy;
- •Gomes 3B appendicitis requiring immersion of the appendicular stump;
- •Pregnancy.
研究组 & 干预措施
Modified ERAS protocol group
Laparoscopic appendectomy with modified ERAS protocol group Preadmission. Not available due to the emergency setting. Preoperative care.
- Patient brochure with a detailed description of the type of pathology, surgery procedure, rehabilitation process, possible complications, and other.
Surgery.
- Low pressure (8-9 mmHg) pneumoperitoneum.
- Routinely remove of appendix mesentery in presence of any signs of its inflammation.
- Additional local anesthesia with 0.25% ropivacaine.
- Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5).
Postoperative care.
- Early mobilization (2 h after surgery)
- Early fluid intake (2 h after surgery)
- Early liquid food (6 h after surgery)
干预措施: Laparoscopic appendectomy (Procedure)
Standard care group
Standard care laparoscopic appendectomy. Preadmission. Not available due to emergency setting. Preoperative care. 1) Patient oral informing about the type of pathology, surgery procedure and possible complications. No brochure.
Surgery.
- Standard pressure (12-14 mmHg) pneumoperitoneum
- Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A).
- Appendix mesentery removing in the appearance of its necrotic changes.
- No intraabdominal anesthesia. Postoperative care.
- Mobilization in 4-6 h after surgery 2) Fluid intake in 6 hours 3) Liquid food intake in 12 hours
干预措施: Laparoscopic appendectomy (Procedure)
结局指标
主要结局
Postoperative length of stay (pLOS)
时间窗: 30 days
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
次要结局
- Postoperative pain(24 hours)
- Readmission rate(30 days)
- Complication rate(30 days)
- Shoulder pain incidence(24 hours)
- Shoulder pain level(24 hours)