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

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: Laparoscopic Cholecystectomy

• Registration Number: NCT04596306
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-08-31
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 876

Inclusion Criteria

• acute calculous cholecystitis

Exclusion Criteria

• tumors of the biliary tract

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OVER 70 Y-O	Laparoscopic Cholecystectomy	-
UNDER 70 Y-O	Laparoscopic Cholecystectomy	-

Primary Outcome Measures

Name	Time	Method
In-hospital morbidity	30 day
In-hospital mortality	30 day

Secondary Outcome Measures

Name	Time	Method
conversion to open rate	30-day
length of stay	30-day
major complication rate	30-day

Trial Locations

Locations (1)

AOUPisana; 🇮🇹 Pisa, Tuscany, Italy