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NCT04596306 Clinical Trial

Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.

Acute Cholecystitis Clinical Trial

Official title:
Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: More Complex But Equally Safe and Effective. A Retrospective Study on 879 Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04596306
Other study ID # DT- 02- 2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date November 30, 2020

Study information
Verified date January 2021
Source Azienda Ospedaliero, Universitaria Pisana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.

Recruitment information / eligibility
Status Completed
Enrollment 876
Est. completion date November 30, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - acute calculous cholecystitis Exclusion Criteria: - tumors of the biliary tract

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy

Locations
Country Name City State
Italy AOUPisana Pisa Tuscany

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital morbidity 30 day
Primary In-hospital mortality 30 day
Secondary conversion to open rate 30-day
Secondary length of stay 30-day
Secondary major complication rate 30-day
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