GB34 Acupuncture in Acute Cholecystitis
GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alirıza Erdoğan, MD
- Numéro de téléphone: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
Lieux d'étude
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Niğde, Turquie
- Recrutement
- Niğde Ömer Halisdemir University Training and Research Hospital
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Contact:
- Alirıza Erdoğan, MD
- Numéro de téléphone: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Controls
Patients will only receive standard medical treatment
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived pain
Délai: 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
|
|
Guarding
Délai: 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
|
|
Rebound
Délai: 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
Délai: Through study completion, an average of 1 year
|
Hemoglobin values expressed as g/dL
|
Through study completion, an average of 1 year
|
|
WBC
Délai: Through study completion, an average of 1 year
|
White blood cell count in microliter
|
Through study completion, an average of 1 year
|
|
NEU%
Délai: Through study completion, an average of 1 year
|
percent of neutrophils
|
Through study completion, an average of 1 year
|
|
LYM%
Délai: Through study completion, an average of 1 year
|
percent of lymphocytes
|
Through study completion, an average of 1 year
|
|
PLT
Délai: Through study completion, an average of 1 year
|
platelet count in microliter
|
Through study completion, an average of 1 year
|
|
CRP
Délai: Through study completion, an average of 1 year
|
C-reactive protein levels expressed in mg/L
|
Through study completion, an average of 1 year
|
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AST
Délai: Through study completion, an average of 1 year
|
Aspartate aminotransferase levels expressed in IU/L
|
Through study completion, an average of 1 year
|
|
ALT
Délai: Through study completion, an average of 1 year
|
Alanine aminotransferase levels expressed in U/L
|
Through study completion, an average of 1 year
|
|
ALP
Délai: Through study completion, an average of 1 year
|
Alkaline phosphatase levels expressed in U/L
|
Through study completion, an average of 1 year
|
|
GGT
Délai: Through study completion, an average of 1 year
|
Gamma glutamyl transferase levels expressed in U/L
|
Through study completion, an average of 1 year
|
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Amylase
Délai: Through study completion, an average of 1 year
|
Amylase levels expressed in U/L
|
Through study completion, an average of 1 year
|
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Total bilirubin
Délai: Through study completion, an average of 1 year
|
Total bilirubin levels expressed in mg/dL
|
Through study completion, an average of 1 year
|
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Direct bilirubin
Délai: 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
Délai: Through study completion, an average of 1 year
|
if patients tolerate oral intake or not
|
Through study completion, an average of 1 year
|
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Analgesic dosage
Délai: Through study completion, an average of 1 year
|
Total dosage of analgesic administered in mg
|
Through study completion, an average of 1 year
|
|
Antibiotic dosage
Délai: Through study completion, an average of 1 year
|
Total dosage of antibiotic administered in mg
|
Through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alirıza Erdoğan, MD, Nigde Omer Halisdemir University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 08.06.2021/32
Plan pour les données individuelles des participants (IPD)
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