GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
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
- Perceived pain
研究概览
简要总结
The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.
详细描述
Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain.
Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients.
In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed and hospitalised patients with mild acute cholecystitis
排除标准
- •Pregnant women
- •Immunosuppressive patients
- •Patients with intermediate and severe acute cholecystitis
- •Patients with acalculous acute cholecystitis
- •Patients with uncontrolled diabetes mellitus
- •Patients with collegen tissue diseases
- •Patients with malignancies
- •Patients who are using anti-coagulant or anti-aggregant medications
- •Patients with blood diseases
- •Patients with BMI>35
结局指标
主要结局
Perceived pain
时间窗: From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours.
Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient.
Analgesic dosage
时间窗: From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.
Total dosage of analgesic administered in mg
次要结局
- Abdominal tenderness(At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.)
- GGT(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- ALT(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- PLT(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- Guarding(At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.)
- Antibiotic dosage(From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours)
- Amylase(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- ALP(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- Hb(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- Oral intake(From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).)
- Total bilirubin(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- Direct bilirubin(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- CRP(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- AST(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- LYM%(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- NEU%(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
- WBC(At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours)
研究者
Alirıza Erdoğan
Principal Investigator
Nigde Omer Halisdemir University