Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis

Acute Calculous Cholecystitis Clinical Trial

Official title:

Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484232
• Other study ID #: Soh-Med-22-07-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: February 2023

Study information

• Verified date: July 2022
• Source: Sohag University
• Contact: sherif A Ahmed, resident
• Phone: 01094995035
• Email: shreif011109[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Calculous Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic Cholecystectomy
Early laparoscopic cholecystectomy in patients with acute calcular cholecystitis

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Review. — View 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. — View Citation

Minutolo V, Licciardello A, Arena M, Nicosia A, Di Stefano B, Calì 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. — View Citation

Ozkardes AB, Tokaç M, Dumlu EG, Bozkurt B, Ciftçi AB, Yetisir F, Kiliç 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of surgery ,	compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy	Intraoperative
Primary	percentage of complications	compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy	6 months
Primary	morbidity	compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy	6 months
Primary	mortality	compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy	6 months