Clinical trial NCT03122054: Early Versus Delayed Cholecystectomy
Official title: Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Keywords: Laparoscopic Cholecystectomy, Delayed Cholecystectomy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients suffering acute pain because of acute cholecystitis
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital stay
timeFrame: 4 to 8 weeks
Secondary outcomes:
measure: Costs of treatment
timeFrame: 4 to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
name: Riza Gurhan Isil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.