Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis

NCT05484232 | Unknown

• 1 other identifier: Soh-Med-22-07-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Calculous Cholecystitis

Outcome Measures

Primary Outcomes (4)

• duration of surgery ,

  compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy

  Intraoperative

• percentage of complications

  compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy

  6 months

• morbidity

  compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy

  6 months

• mortality

  compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy

  6 months

Interventions

Laparoscopic Cholecystectomy PROCEDURE

Early laparoscopic cholecystectomy in patients with acute calcular cholecystitis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient presented by Acute cholecystitis fit for lap cholecystectomy .

You may not qualify if:

• Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 24020050 BACKGROUND

• 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.

  PMID: 24444271 BACKGROUND

• 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.

  PMID: 25749854 BACKGROUND

• 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.

  PMID: 25535191 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Central Study Contacts

sherif A Ahmed, resident

CONTACT

01094995035; shreif011109@med.sohag.edu.eg

Ahmed e Ahmed, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at general surgery department at sohag university

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

EG (1)