Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
Primary Purpose
Cholecystitis, Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis, Acute
Eligibility Criteria
Inclusion Criteria:
- age less than 70 years.
- fit for surgery.
Exclusion Criteria:
- patients with co-existent common bile duct stones based on imaging and biochemical criteria.
- Patients with Pancreatitis .
- Patients with previous upper abdominal surgery.
- Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy
Arm Description
A Prospective Randomized Comparative Study.
Outcomes
Primary Outcome Measures
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
Collect results and see.
Secondary Outcome Measures
Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
Collect results and see.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05502744
Brief Title
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
Official Title
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 14, 2022 (Anticipated)
Primary Completion Date
September 14, 2022 (Anticipated)
Study Completion Date
August 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.
Detailed Description
Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy
Arm Type
Experimental
Arm Description
A Prospective Randomized Comparative Study.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Other Intervention Name(s)
Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopy
Intervention Description
Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.
Primary Outcome Measure Information:
Title
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
Description
Collect results and see.
Time Frame
Intraoperative time
Secondary Outcome Measure Information:
Title
Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
Description
Collect results and see.
Time Frame
6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age less than 70 years.
fit for surgery.
Exclusion Criteria:
patients with co-existent common bile duct stones based on imaging and biochemical criteria.
Patients with Pancreatitis .
Patients with previous upper abdominal surgery.
Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)
12. IPD Sharing Statement
Learn more about this trial
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
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