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

NCT04596306 | Completed

• 1 other identifier: DT- 02- 2020
• Study Type: observational
• Target: 876
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (2)

• In-hospital morbidity

  30 day

• In-hospital mortality

  30 day

Secondary Outcomes (3)

• conversion to open rate

  30-day

• length of stay

  30-day

• major complication rate

  30-day

Study Arms (2)

UNDER 70 Y-O

Procedure: Laparoscopic Cholecystectomy

OVER 70 Y-O

Procedure: Laparoscopic Cholecystectomy

Interventions

Laparoscopic Cholecystectomy PROCEDURE

Laparoscopic Cholecystectomy

OVER 70 Y-O; UNDER 70 Y-O

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy for acute calculous cholecystitis

You may qualify if:

• acute calculous cholecystitis

You may not qualify if:

• tumors of the biliary tract

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

AOUPisana

Pisa, Tuscany, 56126, Italy

Location

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.; M.D., Researcher and Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: November 30, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

IT (1)