Effects of General Health Risk Factors on Prolonged Hospital Stay

February 5, 2025 updated by: Naime Yalçın

Effects of General Health Risk Factors on Prolonged Hospital Stay in Non-operating Room Anesthesia Preoperative Anesthesia Examination; Prospective Study

According to the literature, a detailed preoperative anesthesia assessment systematically verifies perioperative risks, provides functional and physiological optimization, improves the patient's condition and the perioperative process, and prevents complications. In this context, the investigators aimed to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia assessment due to adult gastrointestinal endoscopy, to investigate the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure, and to compare the effects of these risk factors on developing complications and hospital stay.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A detailed preoperative anesthesia assessment systematically validates perioperative risks, optimizes functional and physiological functions, improves patient status and perioperative process, and prevents complications. Preoperative anesthesia assessment clinics are an ideal environment to examine patients' medical conditions, ensure patient safety, and maximize economic efficiency in the preoperative period. The number of procedures performed in outpatient surgery centers has now far exceeded inpatient procedures. With an estimate that 44% of increasingly difficult adverse perioperative events are preventable, it is anticipated that perioperative complications can be reduced through anesthesia clinic examinations. In the absence of clinical examinations, surgical delays and case cancellations due to incomplete patient information will occur. In recent years, the implementation of a large number of complex surgical procedures and the planning of more complicated patients for intervention in the outpatient setting have contributed significantly to the development of day surgery. With the significant increase in the number of patients undergoing outpatient surgery, comprehensive and detailed preoperative assessment and optimization have become increasingly important in patients with multiple comorbidities and unusual conditions. Preoperative screening is essential for patients at risk who may benefit from preoperative optimization. For this purpose, close communication between the surgeon, anesthesiologist, and family physician is essential. There is no doubt that perioperative morbidity and mortality are closely related to the patient's preoperative health status, the surgical procedure performed, and the anesthesia technique used. Various studies have been conducted to confirm and quantify the relationships between risk factors and the incidence of perioperative adverse events. Perioperative factors, accompanied by preoperative risk assessment, help identify patients at increased risk and enable management strategies to reduce postoperative complications and improve patient outcomes. Anesthesia services for gastrointestinal (GI) endoscopic procedures are included in outpatient anesthesia procedures and have increased significantly in frequency over the years. Before 2004, only a fraction of endoscopic procedures were performed with anesthesia, while by 2009, 30-35% of upper endoscopy and colonoscopies were performed with anesthesia under sedation, and this number increased to half of colonoscopies in 2012. Although the use of propofol in endoscopic surgery has increased, the relationship between increased complications due to sedation remains unclear. While some studies have reported increased risk of aspiration pneumonia, colon perforation, bleeding, and cardiovascular events, other studies have shown that there is no increase in the risk of complications during this process. The primary aim of investigator's study was to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia evaluation due to adult gastrointestinal endoscopy. Secondarily, the investigator aimed to compare the effects of these risk factors on complications and hospital stay by investigating the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
580

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
      • İstanbul, Turkey, 34000
        • Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who apply to our hospital's anesthesia outpatient clinic for preoperative anesthesia evaluation for gastrointestinal endoscopy.

Description

Inclusion Criteria:

  • Being over 18 years old
  • ASA I-IV status
  • Undergoing surgery for gastrointestinal endoscopy
  • Under sedation anesthesia

Exclusion Criteria:

  • In case the procedure is performed while awake
  • Emergency endoscopy
  • ASA-E is required

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
General health risk factors
Arm HT, Arm DM, Arm Asthma, Arm Obezity, Arm Immobility, Arm Smoke
Procedure: Gastrointestinal endoscopy
Patients will be divided into groups according to general health risk factors detected during preoperative anesthesia evaluation (hypertension, diabetes, asthma, obesity, chronic disease, medication history, immobility, smoking, etc.) and will be evaluated in terms of age, gender, weight and height will be combined to report BMI in kg/m2, alcohol, allergy, ASA, endoscopy site, complications that may develop related to anesthesia and sedation (such as hemodynamic instability, hemoglobin desaturation, pulmonary aspiration and apnea), additional interventions, and hospital stay.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Association between general health risk factors and prolonged hospital stay
Time Frame: Up to 8 weeks after registration
Investigator planned to divide patients who applied to investigator's anesthesia clinic for gastrointestinal endoscopy into groups according to their general health risk factors (hypertension, diabetes, asthma, immobility, obesity, smoking, etc.) during preoperative anesthesia evaluations, and to primarily determine the number of patients who admitted in the ward after endoscopy despite performing day-case procedures among the groups, and secondarily, to observe the frequency of endoscopy procedures for each group, as well as to examine the length of stay in the recovery unit and complications after the procedure.
Up to 8 weeks after registration

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naime Yalçın

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEK/2024.12.276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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