GB34 Acupuncture in Acute Cholecystitis
GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alirıza Erdoğan, MD
- Telefonní číslo: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
Studijní místa
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Niğde, Krocan
- Nábor
- Niğde Ömer Halisdemir University Training and Research Hospital
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Kontakt:
- Alirıza Erdoğan, MD
- Telefonní číslo: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Acupuncture
GB34 acupuncture will be applied every day.
Patients will receive standard medical treatment
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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.
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Žádný zásah: Controls
Patients will only receive standard medical treatment
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived pain
Časové okno: Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
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Guarding
Časové okno: Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
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Rebound
Časové okno: Through study completion, an average of 1 year
|
presence or absence of abdominal rebound assessed by investigators.
Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
|
Through study completion, an average of 1 year
|
|
Hb
Časové okno: Through study completion, an average of 1 year
|
Hemoglobin values expressed as g/dL
|
Through study completion, an average of 1 year
|
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WBC
Časové okno: Through study completion, an average of 1 year
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White blood cell count in microliter
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Through study completion, an average of 1 year
|
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NEU%
Časové okno: Through study completion, an average of 1 year
|
percent of neutrophils
|
Through study completion, an average of 1 year
|
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LYM%
Časové okno: Through study completion, an average of 1 year
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percent of lymphocytes
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Through study completion, an average of 1 year
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PLT
Časové okno: Through study completion, an average of 1 year
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platelet count in microliter
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Through study completion, an average of 1 year
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CRP
Časové okno: Through study completion, an average of 1 year
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C-reactive protein levels expressed in mg/L
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Through study completion, an average of 1 year
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AST
Časové okno: Through study completion, an average of 1 year
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Aspartate aminotransferase levels expressed in IU/L
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Through study completion, an average of 1 year
|
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ALT
Časové okno: Through study completion, an average of 1 year
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Alanine aminotransferase levels expressed in U/L
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Through study completion, an average of 1 year
|
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ALP
Časové okno: Through study completion, an average of 1 year
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Alkaline phosphatase levels expressed in U/L
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Through study completion, an average of 1 year
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GGT
Časové okno: Through study completion, an average of 1 year
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Gamma glutamyl transferase levels expressed in U/L
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Through study completion, an average of 1 year
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Amylase
Časové okno: Through study completion, an average of 1 year
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Amylase levels expressed in U/L
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Through study completion, an average of 1 year
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Total bilirubin
Časové okno: Through study completion, an average of 1 year
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Total bilirubin levels expressed in mg/dL
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Through study completion, an average of 1 year
|
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Direct bilirubin
Časové okno: Through study completion, an average of 1 year
|
Direct bilirubin levels expressed in mg/dL
|
Through study completion, an average of 1 year
|
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Oral intake
Časové okno: Through study completion, an average of 1 year
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if patients tolerate oral intake or not
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Through study completion, an average of 1 year
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Analgesic dosage
Časové okno: Through study completion, an average of 1 year
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Total dosage of analgesic administered in mg
|
Through study completion, an average of 1 year
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Antibiotic dosage
Časové okno: Through study completion, an average of 1 year
|
Total dosage of antibiotic administered in mg
|
Through study completion, an average of 1 year
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alirıza Erdoğan, MD, Nigde Omer Halisdemir University
Publikace a užitečné odkazy
Obecné publikace
- Bouassida M, Zribi S, Krimi B, Laamiri G, Mroua B, Slama H, Mighri MM, M'saddak Azzouz M, Hamzaoui L, Touinsi H. C-reactive Protein Is the Best Biomarker to Predict Advanced Acute Cholecystitis and Conversion to Open Surgery. A Prospective Cohort Study of 556 Cases. J Gastrointest Surg. 2020 Dec;24(12):2766-2772. doi: 10.1007/s11605-019-04459-8. Epub 2019 Nov 25.
- Arer IM, Yabanoglu H, Caliskan K. Can red cell distribution width be used as a predictor of acute cholecystitis? Turk J Surg. 2017 Jun 1;33(2):76-79. doi: 10.5152/turkjsurg.2017.3392. eCollection 2017.
- Zhou ML, Jia WR, Wang JT, Wang P, Guo LH, Sui MH. [Effect of Electroacupuncture at "Yanglingquan" (GB 34) Acupoint on White Blood Cell Count and Gallbladder Wall Thickness in Rabbits with Acute Cholecystitis]. Zhen Ci Yan Jiu. 2015 Jun;40(3):233-7. Chinese.
- Yeo S, Choe IH, van den Noort M, Bosch P, Jahng GH, Rosen B, Kim SH, Lim S. Acupuncture on GB34 activates the precentral gyrus and prefrontal cortex in Parkinson's disease. BMC Complement Altern Med. 2014 Sep 15;14:336. doi: 10.1186/1472-6882-14-336.
- Na BJ, Jahng GH, Park SU, Jung WS, Moon SK, Park JM, Bae HS. An fMRI study of neuronal specificity of an acupoint: electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neurosci Lett. 2009 Oct 16;464(1):1-5. doi: 10.1016/j.neulet.2009.08.009. Epub 2009 Aug 8.
- Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. doi: 10.1016/0306-9877(95)90117-5.
Termíny studijních záznamů
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Dokončení studie (Očekávaný)
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První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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