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NCT04405713 Clinical Trial

Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

Acute Cholecystitis Clinical Trial

— ACC  

Official title:
Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04405713
Other study ID # early LC for ACC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date March 25, 2020

Study information
Verified date May 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

Description:

This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

Recruitment information / eligibility
Status Completed
Enrollment 900
Est. completion date March 25, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

ACC patients who underwent early LC

Exclusion Criteria:

Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• from the onset of symptoms within the first 3 days
ELC within 3 days of onset of ACC
• : from the onset of symptoms within the 4-7 days
ELC 4-7days of onset of ACC
• from the onset of symptoms beyond 7 days
ELC after 7days of onset of ACC

Locations
Country Name City State
Egypt Mohamed Attea Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Brunée L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: — View Citation

El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2). pii: e2020.00015. doi: 10.4293/JSLS.2020.00015. — View Citation

Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-06 — View Citation

Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized contr — View Citation

Mora-Guzmán I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2019 Aug 6. doi: 10.1007/s11605-019-04335-5. [Epub ahead of pri — View Citation

Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. Epub 2016 Oct 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of postoperative morbidity the incidence of postoperative morbidity during the 30th day of postoperative procedure 30 DAYS
Secondary conversion rate conversion rate to open cholecystectomy INTRAOPERATIVE
Secondary blood loss blood loss intraoperative
Secondary hospital stay overall hospital stay 30 days
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