Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction: a Prospective Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Success rate of conservative treatment
研究概览
简要总结
Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of admission after intra-abdominal surgery. To date, the ideal management of ASBO remains controversial. The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy in patients with ASBO.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants in each group will receive real (with energy output) or sham (without energy output) laser acupuncture. The feelings of participants in each group are not different. The care provider and outcomes assessor don't involve the random allocation and don't know if participants receive real laser acupuncture.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 80 years
- •Clinical symptoms and signs of mechanical obstruction
排除标准
- •Clear non-adhesive etiology of small bowel obstruction (e.g. tumor, hernia)
- •Emergency surgical intervention before being admitted to the hospital
- •Pregnancy
- •Local skin infection on the acupoints, and limb amputees.
研究组 & 干预措施
LA group
The subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), PC6 (Neiguan, B3), ST25 (Tianshu, B3), ST36 (Zusanli, B2), CV4 (Guanyuan), CV12 (Zhongwan, B3).
干预措施: Laser acupuncture (Procedure)
Control group
The subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group.
干预措施: Laser acupuncture (Procedure)
结局指标
主要结局
Success rate of conservative treatment
时间窗: 2 week
Defined as no need for long term nasogastric tube decompression and operative intervention.
次要结局
- Serum motilin(Up to 2 weeks)
- Serum ghrelin(Up to 2 weeks)
- Serum amylase(Up to 2 weeks)
- Serum intestinal fatty acid binding protein (I-FABP)(Up to 2 weeks)
- Time to oral intake(2 weeks)
- Length of hospital stay(Through study completion, an average of 1 year)
- Serum lipase(Up to 2 weeks)
- Serum cortisol(Up to 2 weeks)