EUCTR2017-003835-12-GB进行中(未招募)1 期
A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery - ALLEGRO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 748
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients scheduled for elective colorectal resection for colorectal cancer or diverticular disease at participating UK colorectal surgery units.
- •Right hemicolectomy, extended right hemicolectomy, left colectomy, sigmoid colectomy, subtotal colectomy with ileosigmoid or ileorectal anastomosis and high anterior resection are eligible
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 561
排除标准
- •Planned epidural anaesthesia
- •Planned regional or local infiltration of lidocaine at the same time as lidocaine infusion
- •Current pregnancy or breast feeding
- •Age <18 years
- •Patients lacking capacity to give informed consent.
- •Known or suspected allergy to lidocaine or amide-type local anaesthetics
- •Current complete heart block
- •Current severe liver dysfunction (Child’s A or greater)
- •Current renal failure (eGFR<30)
- •Patients participating in the active intervention phase of another therapeutic clinical trial (or other interventional trial) unless a co-enrollment agreement is in place
- •Patients having surgery for indications other than colorectal cancer/diverticular disease
- •Rectal cancer below the peritoneal reflection in which total mesorectal excision is anticipated
- •Rectal cancer patients who have received any neoadjuvant radiotherapy
- •A preoperative surgical plan to form any new stoma during the primary procedure
研究者
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