Acute Cholecystitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAcupuncture
Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.
Sponsors
Nigde Omer Halisdemir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed and hospitalised patients with mild acute cholecystitis
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived pain | 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 | From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours. | Total dosage of analgesic administered in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Guarding | At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours. | presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease. |
| Abdominal tenderness | At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours. | presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen . |
| Oral intake | From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours). | if patients tolerate oral intake or not |
| Antibiotic dosage | From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours | Total antibiotic dose administered during hospitalization (mg) |
| Direct bilirubin | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Direct bilirubin levels expressed in mg/dL |
| Total bilirubin | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Total bilirubin levels expressed in mg/dL |
| Amylase | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Amylase levels expressed in U/L |
| GGT | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Gamma glutamyl transferase levels expressed in U/L |
| ALP | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Alkaline phosphatase levels expressed in U/L |
| ALT | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Alanine aminotransferase levels expressed in U/L |
| AST | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Aspartate aminotransferase levels expressed in IU/L |
| CRP | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | C-reactive protein levels expressed in mg/L |
| PLT | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | platelet count in microliter |
| LYM% | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | percent of lymphocytes |
| NEU% | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | percent of neutrophils |
| WBC | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | White blood cell count in microliter |
| Hb | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours | Hemoglobin values expressed as g/dL |
Countries
Turkey (Türkiye)
Outcome results
None listed