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NCT Number: NCT06743217

TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMIES IN ELDERLY PATIENTS

Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(<65 years ) via using aforementioned criteria

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery

Istanbul, 34303, Turkey (Türkiye)

About this study

Textbook outcome is a measure used to assess the quality of surgical practice and has been implemented in various areas of surgical literature. It is defined as an uneventful operative and postoperative period that leads to successful surgery without negative outcomes. There is still no consensus on the textbook outcome concept for emergency cholecystectomy. SPRIMACC Collaborative Study has presented and offered a list of textbook outcome criteria.

Their proposal was: no 30-day mortality, no 30-day postoperative complications (any CD≥I is considered non-TO), no readmission within 30 days, and hospital stay≤7 days (75th percentile) and full laparoscopic surgery.

The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(<65 years ) via using aforementioned criteria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients underwent emergency cholecystectomy with a diagnosis of acute choleystitis

Exclusion criteria

  • Patients underwent open surgery directly. Patients diagnosed as malignant postoperatively in the pathology report

Treatment and study plan

Primary outcomes

  1. Textbook Outcome

    Time frame: 30 days

    The Textbook Outcome criteria for emergency cholecystectomy in this study were patients have these criteria: no 30-day mortality, no 30-day postoperative complications, no readmission within 30 days, hospital stay≤7 days and full laparoscopic surgery

Secondary outcomes

  1. Subtotal cholecystectomy

    Time frame: 1 day

    Patients underwent emergency surgery with a diagnosis of acute cholecystitis and subtotal cholecystectoym performed

  2. Postoperative Serious Complications

    Time frame: 30 days

    Postoperative complications that have a Clavien-Dindo Score ≥3 were accepted as serious complication.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

IS THERE A DIFFERENCE IN TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMY IN ELDERLY PATIENTS COMPARED TO OTHERS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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