Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
Primary Purpose
Acute Calculous Cholecystitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Calculous Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- Any patient presented by Acute cholecystitis fit for lap cholecystectomy .
Exclusion Criteria:
- Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones
Sites / Locations
- Sohag University Hospital
Outcomes
Primary Outcome Measures
duration of surgery ,
compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
percentage of complications
compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
morbidity
compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
mortality
compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484232
Brief Title
Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
Official Title
Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks.
Elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment.
Early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Calculous Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy
Intervention Description
Early laparoscopic cholecystectomy in patients with acute calcular cholecystitis
Primary Outcome Measure Information:
Title
duration of surgery ,
Description
compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Time Frame
Intraoperative
Title
percentage of complications
Description
compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Time Frame
6 months
Title
morbidity
Description
compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Time Frame
6 months
Title
mortality
Description
compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient presented by Acute cholecystitis fit for lap cholecystectomy .
Exclusion Criteria:
Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sherif A Ahmed, resident
Phone
01094995035
Email
shreif011109@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed e Ahmed, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24020050
Citation
Gul R, Dar RA, Sheikh RA, Salroo NA, Matoo AR, Wani SH. Comparison of early and delayed laparoscopic cholecystectomy for acute cholecystitis: experience from a single center. N Am J Med Sci. 2013 Jul;5(7):414-8. doi: 10.4103/1947-2714.115783.
Results Reference
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PubMed Identifier
24444271
Citation
Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.
Results Reference
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PubMed Identifier
25749854
Citation
Cao AM, Eslick GD, Cox MR. Early Cholecystectomy Is Superior to Delayed Cholecystectomy for Acute Cholecystitis: a Meta-analysis. J Gastrointest Surg. 2015 May;19(5):848-57. doi: 10.1007/s11605-015-2747-x. Epub 2015 Mar 7.
Results Reference
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PubMed Identifier
25535191
Citation
Minutolo V, Licciardello A, Arena M, Nicosia A, Di Stefano B, Cali G, Arena G. Laparoscopic cholecystectomy in the treatment of acute cholecystitis: comparison of outcomes and costs between early and delayed cholecystectomy. Eur Rev Med Pharmacol Sci. 2014 Dec;18(2 Suppl):40-6.
Results Reference
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Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
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