An interventional study of Laparoscopic cholecystectomy in Acute Cholecystitis, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by South Valley University · Not applicable, Interventional, and Treatment
Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.
Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.
Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.
Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. ELC might be associated with a significant reduction in morbidity and mortality rates, comparable conversion rates, shorter hospital stays, lower costs, and higher patient satisfaction.
Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC. Additionally, 15% of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25% of patients require re-hospitalization for recurrent attacks of AC and biliary colic, biliary pancreatitis, cholangitis, and calcular obstructive jaundice during the interval waiting for the DLC. Furthermore, DLC has a higher cost and is time-consuming.
Prolonged LC (PLC) for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms, and this may be associated with increased perioperative complications and conversion rate. On the contrary, others believed that hyperemia and edema may help the dissection. All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms.
More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms. The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms.
152 studies on the registry are indexed under Cholecystitis, Acute; 36 are open to participants now.
This study's enrollment of 437 is above the median of 90 across 91 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms
Procedure: Laparoscopic cholecystectomy
Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms
Procedure: Laparoscopic cholecystectomy
Removal of gallbladder laparoscopically
Overall morbidity
The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications
Time frame: 30 days
Morbidity
All intra and postoperative complications
Time frame: 30 days
Mortality
Death
Time frame: 30 days
Total length of hospital saty
Duration of hospitalization
Time frame: 3 years
Total Cost
The total cost includes the surgical and medical costs
Time frame: 3 years
Total antibiotic duration
Duration of antibiotic therapy
Time frame: 3 years
conversion rate
conversion from laparoscopic cholecystectomy to open cholecystectomy
Time frame: 3 years
Operative time
duration from first trocar incision to last stitch
Time frame: 3 hours
Lost days of work
Lost days of work
Time frame: 3 years
Plan to share: Yes — After publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: For 1 year
Access criteria: After publication
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Dec 2022, 47 months.
Of 45 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 47 months is above that.
Counting every sponsor, half of 49 studies reached it within 20 months; a quarter within 10 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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