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GB34 Acupuncture in Acute Cholecystitis

14. juli 2021 opdateret af: Alirıza Erdoğan, Nigde Omer Halisdemir University

GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Niğde, Kalkun
        • Rekruttering
        • Niğde Ömer Halisdemir University Training and Research Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acupuncture
GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
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.
Ingen indgriben: Controls
Patients will only receive standard medical treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through study completion, an average of 1 year
Hemoglobin values expressed as g/dL
Through study completion, an average of 1 year
WBC
Tidsramme: Through study completion, an average of 1 year
White blood cell count in microliter
Through study completion, an average of 1 year
NEU%
Tidsramme: Through study completion, an average of 1 year
percent of neutrophils
Through study completion, an average of 1 year
LYM%
Tidsramme: Through study completion, an average of 1 year
percent of lymphocytes
Through study completion, an average of 1 year
PLT
Tidsramme: Through study completion, an average of 1 year
platelet count in microliter
Through study completion, an average of 1 year
CRP
Tidsramme: Through study completion, an average of 1 year
C-reactive protein levels expressed in mg/L
Through study completion, an average of 1 year
AST
Tidsramme: Through study completion, an average of 1 year
Aspartate aminotransferase levels expressed in IU/L
Through study completion, an average of 1 year
ALT
Tidsramme: Through study completion, an average of 1 year
Alanine aminotransferase levels expressed in U/L
Through study completion, an average of 1 year
ALP
Tidsramme: Through study completion, an average of 1 year
Alkaline phosphatase levels expressed in U/L
Through study completion, an average of 1 year
GGT
Tidsramme: Through study completion, an average of 1 year
Gamma glutamyl transferase levels expressed in U/L
Through study completion, an average of 1 year
Amylase
Tidsramme: Through study completion, an average of 1 year
Amylase levels expressed in U/L
Through study completion, an average of 1 year
Total bilirubin
Tidsramme: Through study completion, an average of 1 year
Total bilirubin levels expressed in mg/dL
Through study completion, an average of 1 year
Direct bilirubin
Tidsramme: Through study completion, an average of 1 year
Direct bilirubin levels expressed in mg/dL
Through study completion, an average of 1 year
Oral intake
Tidsramme: Through study completion, an average of 1 year
if patients tolerate oral intake or not
Through study completion, an average of 1 year
Analgesic dosage
Tidsramme: 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
Tidsramme: Through study completion, an average of 1 year
Total dosage of antibiotic administered in mg
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Alirıza Erdoğan, MD, Nigde Omer Halisdemir University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2021

Primær færdiggørelse (Forventet)

1. juli 2022

Studieafslutning (Forventet)

1. juli 2022

Datoer for studieregistrering

Først indsendt

6. juli 2021

Først indsendt, der opfyldte QC-kriterier

10. juli 2021

Først opslået (Faktiske)

13. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 08.06.2021/32

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Akut kolecystitis

3
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