- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03122054
Early Versus Delayed Cholecystectomy
23. april 2017 oppdatert av: Canan Tulay ISIL, Sisli Hamidiye Etfal Training and Research Hospital
Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC).
Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience.
This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC.
This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic.
Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.
All operations and medical treatments were done by surgeons having work experience <2 years.
Studietype
Intervensjonell
Registrering (Faktiske)
176
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- patients suffering acute cholecystitis in their first 72 hours of pain
Exclusion Criteria:
- clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Group L (n:88)
patients treated surgically with laparoscopic cholecystectomy immediately
|
First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure.
Second 10-mm trocar was inserted from subxyphoid area.
Two 5-mm trocars were inserted in the right upper quadrant area.
After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle.
In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula.
Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA).
Gallbladder was dissected from liver bed carefully.
Gallbladder was taken out from abdomen through the subumbilical incision.
|
Annen: Group D (n:88)
patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy
|
First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure.
Second 10-mm trocar was inserted from subxyphoid area.
Two 5-mm trocars were inserted in the right upper quadrant area.
After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle.
In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula.
Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA).
Gallbladder was dissected from liver bed carefully.
Gallbladder was taken out from abdomen through the subumbilical incision.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hospital stay
Tidsramme: 4 to 8 weeks
|
time spent totally in the hospital; time from admission to discharge from hospital in days
|
4 to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Costs of treatment
Tidsramme: 4 to 8 weeks
|
costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
|
4 to 8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Riza Gurhan Isil, MD, Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.
- Gurusamy K, Samraj K, Gluud C, Wilson E, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 2010 Feb;97(2):141-50. doi: 10.1002/bjs.6870. Erratum In: Br J Surg. 2010 Apr;97(4):624.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2015
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
15. februar 2017
Datoer for studieregistrering
Først innsendt
28. mars 2017
Først innsendt som oppfylte QC-kriteriene
17. april 2017
Først lagt ut (Faktiske)
20. april 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHEEAH 12.04.2016/1141
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
I can share study data only without sharing patient names and protocol numbers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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