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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05484232
Other study ID # Soh-Med-22-07-10
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT04744441 - Mortality Risk Estimation in Acute Calculous Cholecystitis: Beyond the Tokyo Guidelines
Completed NCT05135299 - Complications in Acute Calculous Cholecystitis
Completed NCT01894321 - The Clinical Outcomes of the Percutaneous Cholecystostomy, Supportive Care Versus Cholecystectomy. N/A
Completed NCT05125653 - Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy N/A