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OpenTrials
Completed

NCT Number: NCT04596306

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUPisana

Pisa, Tuscany, 56126, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute calculous cholecystitis

Exclusion criteria

  • tumors of the biliary tract

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic Cholecystectomy

Primary outcomes

  1. In-hospital morbidity

    Time frame: 30 day

  2. In-hospital mortality

    Time frame: 30 day

Secondary outcomes

  1. conversion to open rate

    Time frame: 30-day

  2. length of stay

    Time frame: 30-day

  3. major complication rate

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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