Early Versus Delayed Cholecystectomy
Primary Purpose
Acute Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring Laparoscopic Cholecystectomy, Delayed Cholecystectomy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group L (n:88)
Group D (n:88)
Arm Description
patients treated surgically with laparoscopic cholecystectomy immediately
patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
Hospital stay
time spent totally in the hospital; time from admission to discharge from hospital in days
Secondary Outcome Measures
Costs of treatment
costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
Full Information
NCT ID
NCT03122054
First Posted
March 28, 2017
Last Updated
April 23, 2017
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03122054
Brief Title
Early Versus Delayed Cholecystectomy
Official Title
Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
February 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Laparoscopic Cholecystectomy, Delayed Cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients suffering acute pain because of acute cholecystitis
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group L (n:88)
Arm Type
Other
Arm Description
patients treated surgically with laparoscopic cholecystectomy immediately
Arm Title
Group D (n:88)
Arm Type
Other
Arm Description
patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital stay
Description
time spent totally in the hospital; time from admission to discharge from hospital in days
Time Frame
4 to 8 weeks
Secondary Outcome Measure Information:
Title
Costs of treatment
Description
costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
Time Frame
4 to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riza Gurhan Isil, MD
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I can share study data only without sharing patient names and protocol numbers.
Citations:
PubMed Identifier
22570746
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.
Results Reference
background
PubMed Identifier
20035546
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. Erratum In: Br J Surg. 2010 Apr;97(4):624.
Results Reference
result
Learn more about this trial
Early Versus Delayed Cholecystectomy
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