TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMIES IN ELDERLY PATIENTS

December 18, 2024 updated by: Yasir Musa Kesgin, MD, Kanuni Sultan Suleyman Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Acute Cholecystitis

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Istanbul, Turkey, 34303
    - University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients ≥ 18 years old and underwent emergency cholecystectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Group A All patients which are younger than 65 years old and underwent emergency cholecystectomy between 2020 and 2024
Group B- Elderly Group All patients ≥ 65 years old and underwent emergency cholecystectomy between 2020 and 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subtotal cholecystectomy Time Frame: 1 day	Patients underwent emergency surgery with a diagnosis of acute cholecystitis and subtotal cholecystectoym performed	1 day
Postoperative Serious Complications Time Frame: 30 days	Postoperative complications that have a Clavien-Dindo Score ≥3 were accepted as serious complication.	30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Study Chair: Yasir Musa Kesgin, MD, University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital, Department of General Surgery, Istanbul,Türkiye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)