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

• Sponsor: Azienda Ospedaliero, Universitaria Pisana (Other)
• Overall Status: Completed
• CT.gov ID: NCT04596306
• Collaborator: (none)
• Enrollment: 876
• Location: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 79.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Procedure: Laparoscopic Cholecystectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 876 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: More Complex But Equally Safe and Effective. A Retrospective Study on 879 Patients.
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
UNDER 70 Y-O	Procedure: Laparoscopic Cholecystectomy; Laparoscopic Cholecystectomy
OVER 70 Y-O	Procedure: Laparoscopic Cholecystectomy; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcome Measures

1. In-hospital morbidity [30 day]

2. In-hospital mortality [30 day]

Secondary Outcome Measures

1. conversion to open rate [30-day]

2. length of stay [30-day]

3. major complication rate [30-day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• acute calculous cholecystitis

Exclusion Criteria:

• tumors of the biliary tract

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUPisana	Pisa	Tuscany	Italy	56126

Sponsors and Collaborators

• Azienda Ospedaliero, Universitaria Pisana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dario Tartaglia, Ph.D.; M.D., Researcher and Principal Investigator, Azienda Ospedaliero, Universitaria Pisana
• ClinicalTrials.gov Identifier: NCT04596306
• Other Study ID Numbers: DT- 02- 2020
• First Posted: Oct 22, 2020
• Last Update Posted: Jan 19, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute

Study Results

No Results Posted as of Jan 19, 2021